Clinical Trials
Advert for Healthcare Professionals only
Haematology
NOPHO-DBH AML 2012 Protocol Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years
Mar 2013The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.
Cologne Cohort of Neutropenic Patients (CoCoNut)
Mar 2013The Cologne Cohort of Neutropenic Patients (CoCoNut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia (LAMVIRE)
Mar 2013Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥ 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.
Feb 2013To investigate the efficacy, of intravenous volasertib + subcutaneous low-dose cytarabine in patients ≥ 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy. Efficacy will be determined primarily based on remission rate (CR+CRi) and overall survival (OS).
Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (DASAPOST)
Feb 2013Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
Risk Assessment of Febrile Neutropenia and Grade 3-4 Neutropenia in Patients With Non-hematological Cancer Treated With Conventional Chemotherapy (NEURISK)
Feb 2013The purpose of this study is to identify prognostic factors and to develop predictive models of risk of febrile neutropenia and neutropenia grade 3/4 in patients with solid tumors receiving chemotherapy with schemas that have an inherent risk of febrile neutropenia of 10-20%.
A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)
Feb 2013This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
Feb 2013The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.
Phase 1-2 Study of Total Bone Marrow Irradiation With Helicoidal Tomotherapy in 1st Myeloma Relapse (TOMMY)
Feb 2013In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
Feb 2013The main purpose of the study is to evaluate the efficacy and safety of the study drug known as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with sickle cell disease. The study will also investigate reduction in daily pain in children who have sickle cell disease.
Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia. (ITP0511)
Feb 2013This is a Phase II multicentre study. Patients will be administered eltrombopag 50 mg/daily. If patients don't achieve response after 2 months of therapy they will stop eltrombopag; if patients will achieve response after 2 months of therapy, they will continue eltrombopag for a maximum period of 24 months; 40 patients are needed. In stage I, 22 patients will be enrolled; if ≤ 4 responses at the first evaluation after 2 months (18%) will be seen, the trial will be stopped; if 5 or more responses will be seen, the accrual will continue. In stage II, 18 more patients will be enrolled. If ≤ 12 (30%) responses will be observed out of 40 patients, it will be concluded that the study drug is not active enough. If ≥ 13 responses will be observed, it will be concluded that eltrombopag is worth of further studies.
Evaluation of the Efficacy of Platelets Treated With Pathogen Inactivation Process (EFFIPAP)
Feb 2013This study is a multicentre, double-blind, randomized therapeutic trial. The primary objective of this study is to evaluate non-inferiority with regard to prevention and control of haemorrhage: - of platelet concentrates treated by pathogen inactivation (Intercept amotosalen and UVA procedure) - compared with the usual platelet concentrates (in additive solution intersol), reference arm, and - compared with platelet concentrates re-suspended in autologous plasma (historic arm) These three products are available and authorised by ANSM (formerly AFSSAPS). The secondary objectives is to evaluate the transfusion needs, transfusion outcomes and safety and the decreased frequency of grade 2 or higher side effects related to transfusion allergy to platelets.
A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma
Feb 2013To assess the antitumor activity of single-agent MOR00208 in adult patients with relapsed or refractory NHL who have received at least one prior therapy containing rituximab as one of the treatments.
Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital. (ALL)
Feb 2013This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.
Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid Leukaemia (AML)
Feb 2013The purpose of this study is evaluate patients with acute myeloid leukemia (<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital. The purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis
Feb 2013To evaluate the efficacy of FG-4592 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.
Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas (LeMLAR)
Feb 2013Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)
Feb 2013The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granylocyte-colony stimulating factor)G-CSF vrs G-CSF will be compared regarding efficacy, costs and safety.
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients (ENESTFreedom)
Jan 2013The main purpose of the study is to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III non-inferiority study of the EORTC Lymphoma Group.
Jan 2013The main objective of the trial is to show that ABVD-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification in case of a positive FDG-PET/CT after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen.
Whole Body MRI Imaging in Multiple Myeloma at 3 Tesla MRI : Added Value of Diffusion Weighted Imaging
Jan 2013Whole body MRI with diffusion weighted imaging is a useful imaging tool - staging and diagnosis - therapy monitoring All patients will be scanned before and during treatment. The findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and MRI (T1 and STIR)).
A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
Jan 2013The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2) (Nilo Post-STIM)
Jan 2013The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.
A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse
Jan 2013The objective of this study is to explore the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on PFS
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)
Jan 2013The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.
A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia-positive CML after two different durations of consolidation treatment with nilotinib 300mg BID.
Jan 2013To assess the optimal duration of consolidation treatment with nilotinib 300 mg BID in order that patients remain in treatment free remission (≥MR4.0) without molecular relapse 12 months after cessation of nilotinib.
Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.
Jan 2013This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
SST0001 in Advanced Multiple Myeloma
Jan 2013Heparanase cleaves heparan sulfate (HS) chains, a natural substrate for heparanase, and participates in degradation and remodelling of the extra-cellular matrix (ECM) facilitating, among other activities, cell invasion associated with cancer metastasis, angiogenesis, and inflammation. The heparanase enzyme is a promising target for development of new anticancer drugs. HS and the structurally related heparin are present in most animal species. As an analogue of the natural substrate of heparanase HS, heparin is considered to be a potent inhibitor of heparanase. SST0001 is a polymer with a heparin-like structure. It is a reduced oxidized N-acetyl heparin, these modifications cause the reduction of anticoagulant activity and are strictly related to the anti-heparanase activity. In preclinical murine models SST0001 showed a significant anti myeloma effect in multiple myeloma mice xenograft models, with a significant reduction of subcutaneous growth of different multiple myeloma cell lines, when SST0001 was administered either alone or in combination with dexamethasone. The purpose of this study is to determine the safety and tolerability of escalating doses of SST0001 in the treatment of advanced refractory multiple myeloma.
A pilot, exploratory, randomized, phase 2 safety study evaluating tumor cell (plasma cell) mobilization and apheresis product contamination in plerixafor plus non-pegylated G-CSF mobilized patients and in non-pegylated G-CSF alone mobilized patients
Jan 2013To evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib (CML1113)
Jan 2013The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.
A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission
Dec 2012The primary objective of the study is to demonstrate if maintenance therapy with oral azacitidine improves OS compared with placebo in subjects with AML, age >= 55 years, who have achieved first CR or CRi after induction with intensive chemotherapy with or without consolidation chemotherapy
A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia
Dec 2012To establish the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D) of BEZ235 when administered twice daily (BID) as a single agent in patients with relapsed or refractory acute leukemia To determine the dose-limiting toxicity (DLT)
Study of ACE-536 for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Dec 2012The purpose of this study is to evaluate the effects of ACE-536 on anemia in patients with low or intermediate-1 risk MDS.
A single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti–Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
Dec 2012To assess the tumor response rate (defined according to the IMWG uniform response criteria)
A Phase II Trial of combination treatment with Vorinostat, Bortezomib and Dexamethasone in participants with Relapsed Multiple Myeloma
Dec 2012To assess the overall response rate (partial response or better) of patients with relapsed multiple myeloma, after combination treatment with vorinostat, bortezomib and dexamethasone.
A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib
Dec 2012The purpose of this study is to determine the rate of successful treatment-free remission (TFR) within the first 12 months following cessation of treatment in patients who achieved and maintained a molecular response (MR) 4.5 on nilotinib after a switch from imatinib. TFR phase is often referred to as discontinuation phase in other studies.
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Nov 2012Modified progression free survival (mPFS) per independent review facility (IRF)
Multicenter, open-label, non-randomized Phase II trial of dasatinib in patients with Chronic Myeloid Leukemia in Chronic Phase (CP-CML) who meet criteria for late suboptimal response after prior imatinib treatment.
Nov 2012To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
An open label, randomized (2:1) Phase 2b study of Dasatinib vs. Imatinib in patients with Chronic Phase Chronic Myeloid Leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg Imatinib
Nov 2012To compare the rate of major molecular response (MMR) at 12 months after Day 1initiation of first line treatment with imatinib, in patients randomized at month 3 to treatment with dasatinib 100mg QD or imatinib at any dose, after less than optimal response to 1st line imatinib
A four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from a stable dose of recombinant human erythropoietin to GSK1278863 in hemodialysis-dependent subjects with anaemia associated with chronic kidney disease
Oct 2012Estimate the relationship between dose of GSK1278863 and hemoglobin (Hgb) response following switching from a stable dose of rhEPO in subjects undergoing HDD.
Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia
Oct 2012The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)
Oct 2012The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.
A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant
Oct 2012To evaluate the efficacy (as measured by overall survival) of pixantrone plus rituximab compared to gemcitabine plus rituximab in patients with a diagnosis of de novo DLBCL, DLBCL transformed from indolent lymphoma, or follicular grade 3 lymphoma who have relapsed after at least 1 prior chemotherapy regimen and who are not currently eligible for high-dose (myeloablative) chemotherapy and stem cell transplant.
A multicenter, single-arm, open-label study with pomalidomide in combination with low dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma
Oct 2012Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone(LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
Oct 2012To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured by durable platelet response
An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED)
Oct 2012To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission
A prospective phase II study to assess immunophenotypic remission after three-drug in-duction followed by randomized stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma
Sep 2012The objectives of this study is to determinate the rate of immunophenotypic remission after induction treatment with Revlimid Velcade Dexamethasone (RVD) prior to high-dose melphalan and autologous stem cell transplantation (HDT-ASCT), after HDT-ASCT, and during lenalidomide maintenance in patients with multiple myeloma.
A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery
Sep 2012To determine if a single dose of intravenous iron given to patients with anaemia prior to major open abdominal surgery, reduces the need for peri-operative blood transfusion (the peri-operative period is defined as from randomisation to the trial until 30 days following operation)
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
Sep 2012To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease
A safety and efficacy study of adding low dose pegylated ifn-alpha 2b to standard dose dasatinib in patients with newly diagnosed chronic myeloid leukemia
Aug 2012Observe toxicity of drug combination (see protocol) Observe effect measured as response by molecular assessment of BCR-ABL transcript fraction in so called major molecular remission (i.e 3 long below debut levels)
A Three-part Study of Eltrombopag in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension). ASPIRE: A Study of EltromboPag In Myelodysplastic SyndRomes and AcutE Myeloid Leukemia
Aug 2012Part 1 open-label, 8 week first part of the study are: • To evaluate the safety and tolerability of eltrombopag. • To determine optimal dose escalation scheme for use in Part 2 of the study by assessing the dose of eltrombopag required to achieve platelet count response. • To characterize plasma eltrombopag pharmacokinetics (steady-state plasma eltrombopag Cmax, tmax, AUC(0-τ), CL/F, and half-life). Part 2: • The primary objective of this study is to determine reduction in the number of clinically relevant thrombocytopenic events (CRTE) in subjects with MDS or AML who have Grade 4 thrombocytopenia (<25 Gi/L) and are treated with eltrombopag compared to those treated with placebo. Part 3: The objectives of Part 3 of the study are to evaluate the long-term durability of clinical benefit as well as overall survival, the long-term safety and tolerability of eltrombopag in subjects with MDS and AML.”
A Phase II, Open-Label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults using FBS0701 (SSP-004184 ).
Aug 2012Measure the extent and durability of FBS0701 treatment effects; continue to assess the safety, tolerability and efficacy of FBS0701 (SSP-004184) in subjects who received FBS0701(SSP-004184) in prior Ferrokin sponsored study; allow access and assess response to FBS0701 (SSP-004184) in subjects randomised to another chelating therapy in a prior FerroKin-sponsored FBS0701(SSP-004184) study.
Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
Aug 2012The objective of this study is to evaluate the efficacy and safety of BAY 80 6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma (NHL) who have progressed after standard therapy.
Efficacy and feasibility of first-line treatment with risk-adapted dose-adjusted EPOCH-R (DA-EPOCH-R) in patients with Burkitt lymphoma. A phase II clinical trial.
Aug 2012• Determine efficacy, defined as PFS and OS at 2 years of risk-adaptive DA-EPOCH-R in newly diagnosed Burkitt lymphoma patients 18-75 years. • Determine feasibility, defined as > 60% of cycles of the DA-EPOCH-R scheme on an outpatient-clinic basis
A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two FBS0701 Doses in the Treatment of Chronic Iron Overload Requiring Chelation Therapy
Aug 2012Evaluate, in patients with transfusion-dependent iron overload, whose primary diagnosis is hereditary or congenital anemia: - Pharmacokinetic parameters provided a constant (steady state) of two doses of FBS0701; - Changes in the concentrations of iron in the liver, after 12 and 24 weeks following administration of two doses of FBS0701; - The safety and tolerability of two doses of FBS0701, administered daily for 24 weeks.
BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology
Jul 2012The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (breast cancer, Hodgkin's lymphoma).
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia (PAPALDO)
Jul 2012The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Jul 2012To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia
Jul 2012To treat children with ALL with the best available treatment as possible, based upon the risk factors of the patient at diagnosis.
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological malignancies
Jul 2012To investigate whether it is possible to carry out haploidentical/HLA mismatched donor peripheral blood stem cell transplants using high dose cyclophosphamide safely and effectively
Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of octagam 10% in primary immune thrombocytopenia
Jun 2012To assess the efficacy of Octagam 10% in correcting the platelet count (PC).
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma.
Jun 2012To compare the activity of carfilzomib in combination with cyclophosphamide and low dose dexamethasone (CCD) to that of the control treatment of bortezomib, cyclophosphamide and dexamethasone (CVD) in patients with multiple myeloma at first relapse. Specifically the study will assess whether CVD provides non-inferior activity with regard to the short-term outcome measure of ≥Very Good Partial Response rates at 24 weeks, and superior activity in terms of the longer-term outcome measure of progression-free survival.
A Phase II study with a sequential clofarabine-cyclophosphamide combination schedule as salvage therapy for refractory and relapsed acute lymphoblastic leukemia (ALL) in adult patients
Jun 2012The primary objective of this trial is to assess the activity - in terms of percentage of CR - of Clofarabine in combination with Cyclophosphamide in adult patients with refractory and relapsed (≤24 months from first CR) ALL.
A Phase I/IIa trial of VTD-panobinostat treatment and panobinostat maintenance in relapsed and relapsed/refractory multiple myeloma patients
May 2012During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of panobinostat, administered in combination with VTD, in subjects with relapsed and relapsed/refractory multiple myeloma. In the dose expansion phase the purpose of the study is to estimate the response rate (partial response or better) within 16 cycles of VTD-pano at the RD identified in the dose escalation phase.
Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy.
May 2012Co-primary objectives are: 1. To evaluate the rate of MMR at 18 months of nilotinib 300 mg BID monotherapy vs. nilotinib 300 mg BID + pegylated interferon alpha (Peginterferon alpha-2b) 2. To evaluate the rate of continuous MMR after discontinuation of nilotinib vs. interferon alpha.
Phase II Randomised Trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with Relapsed Acute Myeloid Leukaemia ineligible for Intensive Chemotherapy
May 2012To evaluate the activity of azacitidine and vorinostat combined therapy, in terms of overall response (OR) (complete remission (CR), complete remission with incomplete blood count recovery (CRi) and partial remission (PR), as defined by Cheson criteria) and overall survival (OS) in patients with relapsed AML who are ineligible for intensive chemotherapy.
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
May 2012The primary objectives are to evaluate the rate of Grade 2 or higher QTcF prolongation and to evaluate the composite complete remission rate (CRc), defined as the confirmed rate of complete remission (CR) plus complete remission with incomplete platelet recovery (CRp) or incomplete hematological recovery (CRi) at different doses of AC220.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
May 2012To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
May 2012To determine whether the addition of oral MLN9708 to the background therapy of lenalidomide and dexamethasone improves progression-free survival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM)
Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
May 2012This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.
Double blind placebo controlled randomized intervention study aiming at reducing dexamethasone related side effects in children with acute lymphoblastic leukemia (ALL).
May 2012To reduce dexamethasone induced cerebral side-effects on mood, behaviour, and cognition by intervention treatment with physiological doses of cortisol compared to placebo.
An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)
May 2012To compare the hematological remission, defined as CR (both CR and CRi), as reported by the external independent endpoint adjudication committee, in patients with relapsed/refractory ALL randomized to receive inotuzumab ozogamicin (Arm A) versus patients randomized to receive active comparator (Arm B).
Lenalidomide and Dexamethasone With/Without Transplant in Patients With Multiple Myeloma
May 2012The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how many subjects respond to each study treatment combination, how long their responses last, whether they live longer, and what side effects are caused by each combination.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
May 2012To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma
A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
May 2012To compare progression-free survival (PFS) in patients with multiple myeloma relapsed after 1 to 3 prior therapies treated with either carfilzomib plus dexamethasone (Cd) or bortezomib (Velcade®) plus dexamethasone (Vd).
Response-Adapted Sequential Azacitidine And Chemotherapy in Patients > 60 Years Old With Newly Diagnosed AML Eligible for Chemotherapy and allogeneic hematopoietic cell transplantation: A Multicentre Phase I/II study of the East German Hematology and Oncology Study Group (OSHO)
Apr 2012The objective of the trial is to assess efficacy and safety of induction therapy with response-adapted sequential azacitidine and conventional AML induction chemotherapy in patients > 60 years with newly diagnosed AML (at the dose level resulting from the dose evaluation phase of the trial).
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
Apr 2012The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia (HOWLONG)
Apr 2012Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Apr 2012The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.
A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
Apr 2012To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Apr 2012This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients
Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of octagam 10% in primary immune thrombocytopenia
Apr 2012To assess the efficacy of Octagam 10% in correcting the platelet count (PC).
A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase 2/3 Study of LY2127399 in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma
Apr 2012The primary objective of Phase 2 is to select a dose of LY2127399 to assess with bortezomib and dexamethasone in Phase 3. The primary objective of Phase 3 is to compare PFS after treatment with the dose of LY2127399 selected in Phase 2, bortezomib, and dexamethasone, to that of placebo, bortezomib, and dexamethasone in patients with relapsed/refractory MM.
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Apr 2012The Purpose of this trial is: to determine complete response rate (CRR) after six cycles of chemotherapy to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
Mar 2012To establish the safety profile of daratumumab when given in combination with bortezomib and dexamethasone in subjects with relapsed or refractory MM
Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma
Mar 2012The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdomyosarcoma.
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
Mar 2012In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment [complete remission (CR) rate 79% versus 31%, P < 0.0005, respectively]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction [88% vs. 62.5%, P=0.05, for the presence of at least one of them]. One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group.
An Open Label Phase II Study on the Use of Panobinostat in Combination with Bortezomib and Dexamethasone as Induction in Multiple Myeloma Patients Candidate to High-Dose Therapy
Mar 2012To evaluate if the combination of Panobinostat, Bortezomib and high-dose Dexamethasone as induction therapy can increase the complete response (CR) rate in subjects with previously untreated multiple myeloma who are candidates to autologous stem cell transplantation (ASCT).
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma
Mar 2012To determine the best tolerated and effective dose (dose finding) for oral Lenalidomide among 10, 15, 20 e 25 mg dose levels in a 28-day cycle, as associated to a fixed dose of weekly bendamustine (60 mg/m2 on days 1, 8 and 15), based on the best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook in subjects with Recurrent Hodgkin Lymphoma
Phase 2a Single-Arm Safety Study of Elotuzumab in Combination with Thalidomide and Dexamethasone in Subjects with Relapsed and/or Refractory Multiple Myeloma
Feb 2012To determine the safety and tolerability of Thalidomide-dexamethasone-Elotuzumab (TdE) in subjects with relapsed and/or refractory MM as assessed by the incidence of severe (Grade 3 or higher) non-hematologic adverse events (AEs).
An Open-label, Multicenter Phase 1/2 Study of JNJ-40346527, a FMS Inhibitor, in Subjects with Relapsed or Refractory Hodgkin’s Lymphoma
Feb 2012Phase 1: To establish the recommended Phase 2 dose for JNJ-40346527. Phase 2: To determine the overall response rate (complete response [CR] + partial response [PR]) in subjects with relapsed or refractory cHL.
A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma
Feb 2012The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.
Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Feb 2012This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation
Feb 2012This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.
Pseudohyponatremia of Multiple Myeloma is True Hyponatremia
Jan 2012Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.
A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML
Jan 2012To compare the median Event Free Survival (EFS)* and the EFS probability of all AML patients between the temsirolimus and the control group * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.
A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Jan 2012To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of ≥ 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period.
Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication AMLSG 16-10
Jan 2012To evaluate the impact of midostaurin given in combination with intensive induction, consolidation including allogeneic hematopoietic stem cell transplantation and single agent maintenance therapy on event-free survival (EFS) in adult patients with AML exhibiting a FLT3-ITD.
Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
Jan 2012Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse. It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse.
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
Jan 2012To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients – a pilot study
Jan 2012To determine whether intravenous iron given in the first few days following hip fracture is effective in stimulating red cell production.
Registration of Children With CML and Treatment With Imatinib (CML-paed II)
Jan 2012Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Jan 2012This randomized phase II trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Dec 2011All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3). Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement. In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1*, B1*,A2*, B2*, A3*, B3*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B
Dec 2011Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.
HD-R3i - A prospective, randomized, placebo-controlled, international, multicenter phase I/II trial of RAD001 (everolimus) in combination with DHAP as induction therapy in patients with relapsed or refractory Hodgkin Lymphoma
Dec 2011The main objectives of this study are to identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP) and to demonstrate the efficacy of Ever-DHAP as induction therapy
Tasigna in Glivec-resistant or Intolerant Patients in CML
Dec 2011The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.
A Phase 2, Randomized Study of Bortezomib/dexamethasone With or Without Elotuzumab in Subjects with Relapsed/Refractory Multiple Myeloma.
Dec 2011To compare Progression Free Survival between treatment arms in the overall population.
A Randomised Controlled Double-Blind Trial of Intranasal Fentanyl versus Intravenous Morphine in the Emergency Department Treatment of Severe Painful Sickle Cell Crises in Children
Dec 2011The primary objective of this study is to illustrate the comparative efficacy of intranasal fentanyl to IV morphine in reducing severe pain associated with Painful Sickle Cell Crises in the Emergency Department.
Open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients
Nov 2011To demonstrate the lack of immunogenicity of HX575 administered s.c. in the treatment of anemia associated with CKD
A phase III, randomized, active controlled, assessorblinded study of safety and efficacy of Pegylated Apofilgrastim versus US and EU licensed Neulasta® in subjects with stage IIa, IIb or IIIa breast cancer receiving TAC anticancer chemotherapy in adjuvant setting
Nov 2011To demonstrate an equivalent efficacy of Pegylated Apo‐Filgrastim as compared to each of the commercially available US and EU licensed Neulasta® in patients suffering from early breast cancer and receiving TAC (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in adjuvant setting.
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
Nov 2011The objective of this study is to see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.
A multi-center, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficacy of NOX-A12 in combination with a background therapy of bortezomib and dexamethasone (VD) in previously treated patients with multiple myeloma (MM)
Nov 2011To assess the safety and tolerability of NOX-A12 alone (pilot group only) and in combination with VD To determine the overall response rate according to IMWG uniform response criteria (ORR = best response at least partial response(PR))
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
Nov 2011To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured by durable platelet response
A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Oct 2011This phase II trial studies how well giving panobinostat together with lenalidomide works in treating patients with relapsed or refractory Hodgkin lymphoma.
Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile (CoMMpass)
Oct 2011The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients at initial diagnosis and at relapse of disease.
An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
Oct 2011To assess the efficacy of I10E in increasing platelet count and controlling bleedings in patients suffering from primary Immune ThrombocytoPenia (ITP).
Safety and Efficacy Study of Romiplostim to Treat ITP in Pediatric Subjects
Sep 2011The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric subjects with Immune Thrombocytopenia Purpura (ITP) as measured by durable platelet response.
A Three-part Study of Eltrombopag in Thrombocytopenic Subjects with Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension).
Sep 2011Part 1 open-label, 8 week first part of the study are: To evaluate the safety and tolerability of eltrombopag, to determine optimal dose escalation scheme for use in Part 2 of the study by assessing the dose of eltrombopag required to achieve platelet count response, and to characterize plasma eltrombopag pharmacokinetics (steady-state plasma eltrombopag Cmax, tmax, AUC(0-?), CL/F, and half-life). Part 2: The primary objective of this study is to determine reduction in the number of clinically relevant thrombocytopenic events (CRTE) in subjects with MDS or AML who have Grade 4 thrombocytopenia (<25 Gi/L) and are treated with eltrombopag compared to those treated with placebo. Part 3: The objectives of the study are to evaluate the long-term durability of clinical benefit and the long-term safety and tolerability of eltrombopag in subjects with MDS and AML.
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia
Sep 2011Approximately 84 subjects 18 years of age and over who meet all the eligibility requirements will be randomized. Splenectomized subjects must make up at least 35% of the study population. No single platelet count should be greater than 35x109/L. Subjects will be centrally stratified at randomization by splenectomy status, baseline platelet count, and use of concomitant Idiopathic Thrombocytopenia Purpura (ITP) medication at baseline and will be randomized to receive either double-blind E5501 or placebo in a 2:1 ratio. Subjects will receive blinded therapy at a starting dose of 20mg E5501 or placebo once daily. Subjects will be allowed to have their dose titrated up (maximum dose 40mg E5501 or matching placebo) or down (minimum dose 5mg for E5501 or matching placebo) depending on their response to study drug. The goal of dose modification is to maintain the platelet count at levels greater than or equal to 50x109/L and less than or equal to 150x109/L, and to decrease the need for ITP-directed concomitant medications. The study will consist of three phases: prerandomization, Randomization (Core Study) and the extension study. The duration of treatment in the Core study is 26 weeks and the extension study is up to 2 years.
An open label study to determine the efficacy of ferric carboxymaltose in preoperative colorectal cancer related anaemia, and to develop biomarkers to predict response to this treatment strategy
Sep 2011The principal research question is can we reduce the need for peri-operative allogeneic blood transfusion in the treatment group (intravenous ferric carboxymaltose) compared to the control group (oral ferrous sulphate)?
United Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011
Sep 2011The UKALL 2011 trial will examine whether three changes to current standard therapy improves survival and reduces side effects in patients suffering from acute lymphoblastic leukaemia and lymphoblastic lymphoma. The following questions will be answered: 1) Does exposure to the steroid dexamethasone for a shorter period but at a similar total dosage than is currently used during the first month of treatment, result in fewer side effects whilst maintaining efficacy of treatment. 2) Does the use of methotrexate in high dose, reduce risk of relapse involving the central nervous system. 3) Is it possible to omit monthly pulses of vincristine and dexamethasone, currently given for up to 30 months, without increasing the risk of relapse, thereby reducing side effects and improving health related quality of life.
A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study, with an Open-Label Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of E5501 in Subjects with Chronic Hepatitis C Virus Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment
Aug 2011To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)
Aug 2011This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy and surgery, and mortality.
Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant
Aug 2011This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
A phase 1/2a, dose escalation study of CHR-3996 in combination with tosedostat in subjects with relapsed, refractory multiple myeloma
Aug 2011During the dose escalation phase, the purpose of the study is to determine the maximum tolerated dose (MTD) of CHR-3996 and tosedostat administered in combination in subjects with relapsed or refractory multiple myeloma. In the dose expansion phase the purpose of the study is to determine the safety profile of CHR-3996 and tosedostat administered in combination and to estimate the response rate.
Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma
Jul 2011The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4, CD47, and beta 2 adrenergic receptors) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma.
Phase 1 Study of Combotox With Cytarabine in Relapsed/Refractory B-lineage Acute Lymphoblastic Leukemia (ALL)
Jul 2011This study will test different doses of combotox in your disease to find out what dose of this drug can be given safely to patients. Combotox will be given with cytarabine. You might have been given cytarabine as part of your treatment for ALL before; even if you have received cytarabine before, it usually still works when it is given if the leukemia has not completely disappeared with the first treatment (or is "refractory") or if the leukemia has come back (or has "relapsed"). Another purpose of this study is to find out what effects (good and bad) the experimental drug Combotox has on you and your disease (ALL) when combined with cytarabine.
Prediction and Prevention of PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With Acute Lymphoblastic Leukemia
Jul 2011The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.
A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to a 6-month rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
Jul 2011To evaluate the efficacy in term of progression-free survival after randomization (PFSrand) of a subcutaneous (SC) formulation of rituximab in patients who responded to Induction and initial 2 years maintenance therapy (Maintenance I), and were randomized to either prolonged rituximab maintenance until progression (Maintenance II) or observation.
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
Jun 2011The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.
NK Cell Based Non-Myeloablative Transplantation in (AML) Acute Myeloid Leukemia
Jun 2011This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid leukemia (AML). Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
Jun 2011The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years.
A clinical and mechanistic proof of efficacy study with belimumab in chronic immune thrombocytopenia (ITP) patients
May 2011To evaluate whether belimumab can demonstrate clinical efficacy in ITP and To evaluate whether belimumab can modulate anti-platelet autoantibodies in patients with detectable baseline levels of these antibodies
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma
May 2011This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn’s Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2)
May 2011To demonstrate the effectiveness of oral ST10-021 in the treatment of iron deficiency anaemia in patients with non-active Crohn's Disease where oral ferrous preparations have failed or cannot be used.
Lenalidomide, Lenalidomide + Azacitidine, or Standard Treatment Therapies in Newly Diagnosed Acute Myeloid Leukemia
May 2011The aim of the study is to investigate the effect of a lenalidomide regimen or a sequential azacitidine plus lenalidomide regimen relative to the conventional care regimens in subjects 65 years or older with newly diagnosed Acute Myeloid Leukemia (AML).
PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years
May 2011The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity.
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
May 2011The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults
May 2011The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1).
May 2011To demonstrate the effectiveness of oral ST10-021 in the treatment of iron deficiency anaemia in patients with non-active ulcerative colitis where oral ferrous preparations have failed or cannot be used.
Patient Activation, Consultation and Exercise - Acute Leukemia (PACE-AL)
May 2011The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
A multicenter, phase III, open-label, randomized study in previously untreated patients with advanced indolent non-hodgkin's lymphoma evaluating the benefit of GA101 (RO5072759) plus chemotherapy compared with rituximab plus chemotherapy followed by GA101 or rituximab maintenance therapy in responders
May 2011Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years
Study of Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Minimal Residual Disease in Acute Myeloid Leukemia
May 2011Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.
An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease
Apr 20111. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Extension Study. 2. To assess the ability to achieve stable Hb (Hb ≥ 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.
Twelve-month study on the immunogenicity, safety, and efficacy of Zarzio®/Filgrastim HEXAL® in patients with severe chronic neutropenia
Apr 2011The primary objective of this study is to evaluate the immunogenicity of long-term treatment of SCN patients with Sandoz’ filgrastim in terms of the incidence of anti-rhG-CSF antibodies.
A Phase I/II, Multi-centre Trial to Assess the Safety, Efficacy, and Pharmacokinetics of Eltrombopag, Administered to Thrombocytopenic Chronic Lymphocytic Leukemia Patients Prior to Alkylating Agents and/or Purine Analogue-based Therapy
Apr 2011Phase I: The primary objective is to find the safe and potentially efficacious dose of eltrombopag to achieve a durable increase in platelet count. Phase II: The primary objective of phase II is to confirm the effect of the selected dose from Phase I in correcting thrombocytopenia to enable patients to receive alkylating agents and/or purine analogue-based therapy.
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
Apr 2011The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia (CIT) receiving the combination of carboplatin and paclitaxel chemotherapy (with or without trastuzumab for breast cancer patients).
A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with intravenous BHQ880, a fully human, anti-Dickkopf1 (DKK1) neutralizing antibody in previously untreated patients with high-risk, smoldering multiple myeloma
Apr 2011Assess the overall response rate after BHQ880 treatment in previously untreated patients with high-risk SMM
Safety of Vorinostat in combination with Bortezomib, Doxorubicin and Dexamethasone (VBDD) in patients with refractory or relapsed multiple myeloma
Apr 2011Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D).
Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia
Apr 2011To assess the efficacy of NewGam in correcting the platelet count.
GDC-0449 in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma Who Received an Autologous Stem Cell
Apr 2011This phase I trial is studying how well GDC-0449 works in treating patients with high-risk first remission or relapsed multiple myeloma who received an autologous stem cell transplant.
Eltrombopag for Moderate Aplastic Anemia
Apr 2011To evaluate the safety and effectiveness of eltrombopag in people with moderate aplastic anemia who need treatment for significantly low blood cell counts.
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood Loss
Mar 2011The main objective of this study is to evaluate the effect of the administration of ferric carboxymaltose on transfusion requirements (units of packed cells)
Treatment Protocol for young adults (18-45 years of age) with Acute Lymphoblastic Leukemia
Mar 2011To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect. To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed. To test if replacing six doses of conventional triple i.t. therapy with DepoCyte® during maintenance therapy for HR-ALL will yield an equal or reduced rate of serious toxicity (SAEs and SUSARs) with a similar or decreased CNS- and overall relapse rate
Pre-hospital Risk Factors for Invasive Fungal Infection (SEIFEM 2010)
Mar 2011SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders
Mar 2011To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment for chronic leg ulcers in individuals with sickle cell disease or other red blood cell disorders.
Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
Mar 2011This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
Mar 2011This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
Use of Interim PET Scan to Modify Therapy in Advanced Hodgkin's Lymphoma in Order to Improve Outcomes
Feb 2011this study is an attempt to improve the outcome in the small subset of poor responders to ABVD chemotherapy by the early use of Escalated BEACOPP chemotherapy
Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT): A phase 1/2 study of lenalidomide (Revlimid) in combination with cyclophosphamide (endoxan) and prednisone (REP) in relapsed/refractory multiple myeloma
Feb 2011Phase 1 Primary objective - To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. Phase 2 pimary objective - To investigate the efficacy of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone at the RDL, as determined by the (s)CR+VGPR+PR rate.
An Open-Label, Multi-Center Phase I/IIa Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Oral Tasidotin HCL in Patients with Relapsed/Refractory Aggressive Non-Hodgkin’s Lymphomas
Feb 2011To determine the safety and tolerability of Tasidotin HCl administered orally for 14 consecutive days every 28 days cycle by identifying the MTD when administered in patients with relapsed/refractory aggressive non-Hodgkin’s lymphomas
GCPGC in Chemotherapy-induced Neutropenia
Feb 2011This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC and stage II is multi-center, parallel-group, open label,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to daily filgrastim
An open-label, randomized, phase 3 study of inotuzumab ozogamicin administered in combination with rituximab compared to defined investigator’s choice therapy in subjects with relapsed or refractory CD22-positive aggressive non-hodgkin lymphoma who are not candidates for intensive high-dose chemotherapy
Feb 2011To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.
Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
Feb 2011The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.
A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
Feb 2011To evaluate tumor regression as determined by ORR in patients receiving CAL-101 for treatment of iNHL refractory to rituximab and alkylating agents
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (Vandevol)
Jan 2011The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).
A phase II study to investigate the efficacy of cyclophosphamide as sole graft-versus-host-prophylaxis after allogeneic stem cell transplantation (OCTET-CY)
Jan 2011To assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism.
Randomized phase II Trial comparing Lenalidomide with lowdose dexamethasone versus Lenalidomide in Second Line Multiple Myeloma (MM)
Dec 2010To assess efficacy (TTP) of maintenance treatment with lenalidomide alone compared to a regimen with lenalidomide and low dose dexamethasone
Patient Reported Outcomes in Chronic Myeloid Leukemia
Dec 2010The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.
Eltrombopag for the treatment of thrombocytopenia due to low- and intermediate risk myelodysplastic syndromes.
Nov 2010To evaluate 1. Response rate: The proportion of patients achieving a complete response (CR) or response (R) during the six month treatment period, for subjects receiving eltrombopag relative to placebo (see Platelet Response Section 5.4.4) 2. Safety and tolerability in terms of frequency of adverse events (AE)s and serious adverse events (SAE), for subjects receiving eltrombopag relative to placebo.
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Remission Induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)
Nov 2010To determine the prophylactic efficacy of AmBisome compared to placebo in preventing IFIs in subjects with ALL undergoing remission-induction chemotherapy.
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)
Nov 2010The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
Iron Mediated Vascular Disease in Sickle Cell Anemia Patients
Nov 2010The purpose of this research study is to determine the frequency and severity of iron overload in patients with Sickle Cell Anemia and its relationship to blood vessel function.
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
Oct 2010The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
A 5-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients (FISCO)
Oct 2010A long term observational study in sickle cell disease will enhance the understanding of the disease patterns, current transfusion practices, treatments and outcomes in sickle cell disease.
A prospective open-label randomized study to determine the effects of intravenous Iron administration on markers of kidney injury in chronic kidney disease (CKD)
Oct 2010To assess whether two preparations of intravenous iron therapy affect markers of kidney injury including NGAL levels in serum and urine as a result of intravenous Iron therapy in patients with chronic kidney disease (CKD). The primary objectives of this study are to: To assess the effects of two preparations of intravenous (IV) iron in a cohort of CKD patients with biochemical functional or absolute iron deficiency (ferritin level less than 200 g/l or/and transferrin saturation of <20%) on measures renal injury. To determine whether iron sucrose and iron dextran differ in their effects on markers of renal injury in comparison to baseline measures during the lead in period. To determine whether IVI iron leads to potential transient AKI from assessment of changes in markers of renal injury from baseline markers prior to iron administration.
An open label, multi-centre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 vs 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma
Oct 2010The primary objective of this study is to determine the optimum dose of bendamustine when combined with thalidomide and dexamethasone (BTD) in the treatment of relapsed/refractory multiple myeloma, based on response rates, tolerability, and progression-free survival (PFS).
Determining the Maximum Tolerated Dose of Low Dose Interferon-alfa in Conjunction With Nilotinib in Imatinib Resistant and/or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) (NICOLI)
Oct 2010This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in imatinib resistant and/or intolerant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma
Sep 2010The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM).
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias
Sep 2010Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis. The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.
PONATINIB for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) (PACE)
Sep 2010The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the T315I mutation.
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
Sep 2010The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole.
Efficacy of Dexamethasone Switch in Prednisolone Resistant Adult ALL and Prolonged L-asparaginase in Non-interrupted Schedule
Aug 2010Evaluation of blast clearance in b/m after 7 days of prednisolone prephase and the efficacy of its substitution by dexamethasone if blast count is 25% and more. Feasibility for adults of "no interruptions" protocol with 8 weeks induction and 14 weeks consolidation followed by 2-years maintenance. Tolerability and efficacy in adults of the prolonged L-asparaginase application (total proposed dose 560.000 IU) Feasibility and efficacy of autologous HSCT for T-cell ALL.
A phase 2, interventional, single arm study describing platelet responses and itp remission rates in adult subjects with immune thrombocytopenia purpura receiving romiplostim
Aug 2010The primary objective is to describe the number of months with a subject platelet response over a 12 month treatment period.
A multi-centre, single intravenous dose, exploratory dose-finding, open label trial on the safety and efficacy of Sym001 in the treatment of Immune Thrombocytopenic Purpura (ITP) in RhD positive, non-splenectomized adult subjects
Aug 2010To evaluate the safety of Sym001 following a single intravenous dose, at multiple dose levels, in the treatment of ITP in RhD positive, non-splenectomized adult subjects
Pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease
Aug 2010To determine the pharmacokinetics of anidulafungin given once in every 2 days (q48h) or once in every 3 days (q72h) to patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS
Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
Aug 2010To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma. To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen.
Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma
Aug 2010To evaluate the effect of Lenalidomide given after reduced intensity conditioned stem cell transplant on progression-free survival at 2 years in myeloma
Effect of AT7519M Alone and AT7519M Plus Bortezomib in Patients With Previously Treated Multiple Myeloma
Aug 2010The purpose of this study is to determine whether AT7519M alone or AT7519M plus bortezomib are effective treatments in patients with previously treated multiple myeloma.
Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
Aug 2010The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lymphoblastic leukaemia.
Aug 2010Assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL) primary objective:-To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
Study to Assess Safety and Tolerability of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Aug 2010The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dosing level and regimen for later-stage clinical trials.
An Open-Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination with Bortezomib in Subjects with Relapsed and/or Refractory Multiple Myeloma
Aug 2010•To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); •To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II).
LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
Jul 2010The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.
Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT (PADIMAC)
Jul 2010What is the 2-year progression-free survival (PFS) for patients who, having achieved CR/VGPR following PAD therapy, do not receive any further treatment until clinical indication of relapse? This question is addressed separately for patients who are minimal residual disease positive (MRD+), and those who are MRD negative (MRD-), at end of induction chemotherapy.
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients
Jul 2010The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with chronic myeloid leukemia (CML). The safety of this drug will also be studied.
An open-label, treatment-option protocol of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma
Jul 2010•To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL) •To assess the safety and tolerability of brentuximab vedotin •In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL).
A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia
Jun 2010To evaluate the efficacy of blinatumomab to induce complete MRD response
Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients
Jun 2010The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QoLESS AZA-AMLE)
Jun 2010To evaluate 1. Overall survival (OS) at 2 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive. 2. Disease-free survival (DFS) at 2 years. Events for DFS in both arms are death and first relapse (either AML or MDS recurrence). 3. Changes in quality of life from diagnosis in both arms.
An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximab-refractory, indolent Non-Hodgkin’s Lymphoma
Jun 2010To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used in combination with bendamustine compared with bendamustine alone in patients with indolent NHL refractory to prior rituximab-containing therapy
Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Jun 2010This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia.
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML
May 2010For part A of the study (if applicable): 1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and select the feasible dose level for part B 2. To assess in a randomized comparison the effect of lenalidomide on the CR rate. For part B: 1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) as regards the selected dose level of lenalidomide 2. To assess in a randomized comparison the effect of lenalidomide on the CR rate.
A Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia
May 2010The purpose of this research is to test the effects of L-glutamine on red blood cells of patients with Sickle Cell Anemia or Sickle ß0-Thalassemia.
Quantification de la régression de l'albuminurie et de l'atteinte endothéliale dans une population de patients drépanocytaires homozygotes hyperfiltrants traités par inhibiteurs du système rénine-angiotensine - Etude " RAND "
May 2010Le but premier de cette étude est de quantifier dans la néphropathie drépanocytaire (au stade d'une hyperfiltration glomérulaire associée à une micro/macroalbuminurie) l'effet de l'inhibition du système rénine angiotensine aldostérone sur la micro/macroalbuminurie.
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response (SENSOR)
May 2010To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.
A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)
Apr 2010The primary objective of this study is to compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC.
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma.
Apr 2010The primary objectives of this phase I/II study are to identify the most appropriate dose of Carfilzomib in combination with a standard Melphalan Prednisone (MP) treatment regimen (phase I) and to evaluate the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR), consisting of complete response (CR), very good partial response (VGPR), and partial response (PR) (phase II)].
Osteonecrosis in Children With Acute Lymphoblastic Leukemia
Apr 2010Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.
An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL)
Apr 2010The primary objective of the study is to determine the efficacy, as measured by overall response (complete response [CR] + partial response [PR]), of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin’s Lymphoma (NHL).
A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age (IFM/DFCI 2009)
Mar 2010To compare progression-free survival (PFS) between Arm A and Arm B
An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy
Mar 2010To assess the long-term safety of S-888711
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Mar 2010This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients
Mar 2010This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the BC Cancer Agency Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and Imatinib (IM) for patients with Chronic Myeloid Leukaemia (CML) in Cytogenetic Response (CyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR)
Mar 2010To provide preliminary evidence that HCQ given in combination with imatinib is more effective than imatinib alone in terms of BCR/ABL levels in CML patients who are in major cytogenetic response with residual BCR/ABL+ cells after at least one year of imatinib treatment. To determine the safety and tolerability of HCQ given in combination with imatinib in these patients.
The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.
Mar 2010To test the hypothesis that Globifer Forte treatment leads to a better resolution of anaemia compared to ferrous sulphate in inflammatory bowel disease patients in 12 weeks.
Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma
Mar 2010This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.
A Phase 1b/II, Multicenter, Open-Label, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma. Elotuzumab (formerly HuLuc63)
Mar 2010For Phase 1 portion: To identify the maximum tolerated dose of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with relapsed multiple myeloma. For Phase 2 portion: To evaluate the efficacy of elotuzumab given in combination with lenalidomide and dexamethasone in subjects with multiple myeloma after 1 to 3 prior therapies.
UKALL14 - A randomized trial for adults with newly diagnosed acute lymphoblastic leukemia
Mar 2010To determine if the addition of monoclonal antibody to standard induction chemotherapy results in improved event free survival in patients with precursor B-cell ALL (aim 1B). To determine if the addition of nelarabine improves outcome for patients with T cell ALL (aim 1T)
Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure (BM-CHF)
Mar 2010The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.
A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy
Mar 2010The objective is to compare the efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib (Velcade®) and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who have received one previous therapy.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy.
Mar 2010To assess the efficacy of three dose levels of S-888711 (0.50 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches. To assess the safety and tolerability of imatinib in pediatric patients age 1 to less than 4 during the study period.
An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B) in children with acute lymphoblastic leukaemia.
Feb 2010To characterise the bioavailability of a single 50 mg fixed dose of the O4CP innovative oral liquid formulation versus 50mg registered adult tablets and to assess the pharmacokinetics of an adjusted dose of the O4CP innovative oral liquid formulation given daily for 6 weeks
A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Feb 2010To establish effectiveness of ofatumumab in combination with bendamustine in patients with indolent B-cell NHL disease relapsed after rituximab therapy
A phase II, multi-center, non-randomized, open-label study of TKI258 in patients with relapsed or refractory multiple myeloma, who are with or without t(4;14) translocation
Feb 2010To assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are • with t(4;14) translocation (Group 1). • without t(4;14) translocation (Group 2).
LAM07: Study to Analyze the Efficacy of a Risk Adapted Treatment Strategy, Including Gemtuzumab Ozogamicin (GO) During Consolidation, for Patients With Acute Myeloid Leukemia (AML)
Dec 2009Prospective, multicenter, uncontrolled cohort study to analyze the efficacy of a risk adapted treatment strategy, including gemtuzumab ozogamicin (GO) during consolidation, for patients with acute myeloid leukemia (AML).
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma (SAPHIRE)
Dec 2009The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Ischemic Heart Failure: a randomized placebo controlled trail.
Dec 2009We intend to assess the efficacy of cardiac stem cell therapy in ischemic heart failure patients. Specifically, we want to answer the question whether injection of autologous mononuclear bone marrow cells (BMCs) into the myocardium of no-option patients with ischemic heart failure leads to an improvement in Quality of Life, exercise capacity, myocardial perfusion and myocardial function.
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma
Dec 2009The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab and Either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Dec 2009To evaluate the efficacy of pegfilgrastim, as compared with placebo in reducing the incidence of grade 3/4 febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer treated with bevacizumab and either FOLFOX or FOLFIRI. Grade 3/4 FN is defined as a temperature ≥ 38.0°C (≥ 100.4°F) and ANC < 1.0 × 109/L, where ANC is measured the same day or within a 24 hour window of a temperature ≥ 38.0°C or (≥ 100.4°F).
Study of LBH589, A Deacetylase Inhibitor in Patients With Recurrent or Refractory Hodgkin or Non-Hodgkin's Lymphoma
Dec 2009The purpose of this study is to find out the effects of a drug called LBH589 when given to people with recurrent or refractory Hodgkin or Non-Hodgkin's lymphoma. The safety of this drug will also be studied. The participants' physical state, changes in the size of the tumor, or state of Hodgkin or non-Hodgkin's Lymphoma, and laboratory findings taken while on-study will help the researchers decide if LBH589 is safe and effective.
Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas
Dec 2009The primary objective of this study is to test whether giving campath (alemtuzumab) in combination with continuous infusion EPOCH-R chemotherapy will improve the outcome of lymphoma treatment.
An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease
Nov 2009To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron deficiency anaemia (IDA).
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Nov 2009This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.
Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
Nov 2009The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate EPO dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.
A phase Ib, open-label, multi-center dose-finding study of oral panobinostat (LBH589) in combination with ara-C and mitoxantrone as salvage therapy for refractory or relapsed acute myeloid leukemia
Nov 2009To determine the maximum-tolerated dose (MTD) in terms of the incidence of dose-limiting toxicity (DLT) of panobinostat in combination with ara-C and mitoxantrone at a fixed dose in adult patients with relapsed or is primary refractory acute myeloid leukemia (AML).
Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation
Nov 2009The objective of the trial is to evaluate the therapeutic effects of NIL and IM given in turn (in rotation) in terms of Disease-Free Survival (DFS) at 24 weeks (after 4 courses of treatment).
Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease
Oct 2009The purpose of this research study is to determine the effectiveness and safety of vorinostat when used to treat SCD.
An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects with immune (Idiopathic) Thrombocytopenia Purpura (ITP).
Oct 2009The primary objective of this study is to evaluate the safety of romiplostim as a long-term treatment in pediatric thrombocytopenic subjects with immune (idiopathic) thrombocytopenic purpura (ITP).
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia
Oct 2009Phase I part: - To assess the MTD and the dose-limiting toxicities (DLTs). Phase II part: - To assess the objective response rate at the recommended dose defined in the phase I part. - To assess the safety and tolerability.
A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia
Jul 2009To demonstrate that intravenous iron oligosaccharides is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to IBD, evaluated as the ability to increase haemoglobin (Hb).
A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP
Jul 2009To assess the efficacy of eltrombopag, relative to placebo, in achieving a platelet count ≥50Gi/L at any time during a 6 week treatment period when administered to previously treated pediatric subjects with chronic ITP.
A Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Aplastic Anemia Patients With Immunosuppressive-Therapy Refractory Thrombocytopenia
Jun 2009We now propose this Phase 2, non-randomized pilot study of eltrombopag in aplastic anemia patients with immunosuppressive therapy refractory thrombocytopenia. Subjects will initiate study medication at an oral dose of 50 mg/day (25 mg/day for East Asians), which will be increased or decreased as clinically indicated to the lowest dose that maintains a stable platelet count 20,000/(micro)L above baseline while maximizing tolerability.
Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation
Jun 2009To assess the efficacy of Dasatinib therapy in chronic and accelerated phase BCR-ABL (+) CML patients that undergo molecular, cytogenetic or haematological relapse following SCT.
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
May 2009This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.
Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
May 2009This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.
A Prospective, Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)
May 2009This is a prospective, phase IV, multi-center, open label, study evaluating the changes in bone marrow reticulin and collagen in adult subjects receiving romiplostim for the treatment of thrombocytopenia associated with ITP.
PAVES: Pegfilgrastim Anti-VEGF Evaluation Study
May 2009This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in subjects with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).
A prospective, phase IV, open-label, multi-center study evaluating changes in bone marrow morphology in adult subjects receiving romiplostim for the treatment of thrombocytopenia associated with immune (idiopathic) thrombocytopenia purpura (ITP)
May 2009The primary objective of this study is to evaluate the incidence of collagen fibrosis as evidenced by trichrome staining at Year 1, Year 2, or Year 3 after initial exposure of romiplostim.
Tissue Sample Collection From Patients With Fanconi Anemia
May 2009This laboratory study is collecting and storing tumor tissue samples from patients with Fanconi anemia.
Intravenous Iron: biomarkers and treatment strategies in anaemic Colorectal cancer patients.
May 2009Does the use of intravenous iron provide a safe and effective treatment for anaemia in surgical patients and does the use of intravenous iron lead to a reduction in allogenic blood transfusion?
An open label phase II trial of Clofarabine and Temsirolimus in older patients with relapsed or refractory Acute Myeloid Leukemia (AML)
Mar 2009The primary objective of the trial is to determine the complete response rate (CR/CRi) of older patients with relapsed or refractory AML when given 1 or 2 courses of low-dose Clofarabine combined with Temsirolimus.
A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA) versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).
Mar 20092 years diease free survival following first remission achievement (CR or CRp) in younger patients with intermediate-risk or unfavorable-risk AML
An open-label, multi-centre, clinical study to collect information on the clinical use of argatroban in patients with heparin induced thrombocytopenia (HIT) Type II who require parenteral antithrombotic therapy.
Mar 2009To collect data on the clinical management of argatroban in subjects with heparin induced thrombocytopenia Type II who require parenteral antithrombotic therapy in France.
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Feb 2009Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
CML-SCT -IBFM Study Allogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures.
Feb 2009To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen. To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention
A clinical open, randomised study of oral iron (Duroferon®) vs. intravenous iron (Ferinject®) for iron substitution in blood donors.
Feb 2009To investigate whether there is a difference in the change of blood haemoglobin (Hb) levels between blood donors receiving intravenous iron (Ferinject®) vs. the Swedish standard iron substitution regimen of oral iron (Duroferon®) at visit 2, compared to baseline.
Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
Feb 2009This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy.
A Study of RO5072759 in Combination With Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
Jan 2009This 6 arm study will assess the safety and efficacy of RO5072759 given in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), FC (fludarabine, cyclophosphamide) or bendamustine chemotherapy in patients with CD20+ B-cell follicular non-Hodgkin's lymphoma. Patients with relapsed or refractory disease will be assigned by physician choice to either the CHOP treatment arm, to receive a maximum of 8x3weekly cycles of treatment, or the FC treatment arm, to receive a maximum of 6x4weekly cycles of treatment, and will then be randomized to receive combination treatment with RO5072759 either at a dose of 400 mg iv for all infusions, or at a dose of 1600 mg iv for the first 2 infusions, followed by 800 mg for all subsequent infusions. Previously untreated patients will receive first-line treatment with RO5072759 at a dose of 1000 mg for either a maximum of 8x3 weekly cycles in combination with CHOP or for a maximum of 6x4 weekly cycles in combination with bendamustine. The anticipated time on study treatment is 3-27 months.
The pharmacokinetics of anidulafungin during continuous venovenous hemofiltration
Jan 2009The study is conducted to investigate the pharmacokinetics of anidulafungin during CVVHDF in critically ill patients.
Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial
Dec 2008Investigators thus plan to conduct a chart review of these patients to study their treatment course before their initial evaluation at MDACC, and between and during visits to MDACC.
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
Dec 2008All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles.
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)
Dec 2008Nordic Society of Paediatric Haematology and Oncology (NOPHO) Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Efficacy of Individualised 6MP Dosing During Consolidation Therapy.
A Phase II Study of Oral Panobinostat in adult patients with Relapsed/Refractory classical Hodgkin’s Lymphoma after High-dose Chemotherapy with Autologous Stem Cell transplant.
Nov 2008To determine the objective response rate to therapy with oral panobinostat in patients with refractory/relapsed classical HL using modified response criteria for malignant lymphoma
Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
Nov 2008In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia
Nov 2008The primary objective of this study is to evaluate the pharmacokinetics (PK) of posaconazole (POS) administered orally at three dosage levels to immunocompromised children aged 3 months to <18 years with neutropenia or expected neutropenia.
A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs.
Oct 2008To demonstrate non-inferiority of MIRCERA® versus reference ESAs in terms of a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction (MI), stroke).
Early salvage with high dose chemotherapy and stem cell transplantation in advanced stage Hodgkins lymphoma patients with positive positron emission tomography after two courses of ABVD (PET-2 positive) and comparison of radiotherapy versus no radiotherapy in PET-2 negative patients.
Sep 2008To evaluate if patients considered a failure of the initial treatment, for residual PET positivity after the first two courses of ABVD (PET-2 positive), can be salvaged with an early shift to high-dose chemotherapy supported by stem cell rescue.
A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (sequential high dose cytosine arabinoside and mitoxantrone) versus Standard Double Induction for Initial Chemotherapy of Adult Patients with Acute Myeloid Leukemia
Aug 2008Overall response rate (ORR), aiming at a 15% increase in the CR (complete remission)/CRi (incomplete peripheral recovery) rate by S-HAM induction versus conventional double induction [TAD – HAM for younger patients, HAM (- HAM) for elderly patients].
Front-line treatment of Philadelphia positive (Ph pos), BCR-ABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study.
Jul 2008To assess the complete cytogenetic response rate at 12 months
A randomised, double-blind, placebo-controlled study to assess the safety and activity of pentosan polysulfate sodium on microvascular blood flow, vascular endothelial injury, and vasoocclusive pain in patients with sickle cell disease
Jul 2008To assess the safety and tolerability of pentosan polysulfate sodium administered daily for three months to patients with sickle cell disease
A phase II multi-center, open-label, study of Nilotinib at a dose of 300mg twice daily in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
Jul 2008To establish the Complete Cytogenetic Response Rate at 6 months.
ALFA 0703 : A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Chemotherapy or azacitidine as salvage therapy and Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML)
Jun 2008Untreated AML patients aged more than 65 will be subjected to two randomizations (R1 and R2), in this study. The primary objective of the first randomization (R1) is to assess the benefit in terms of Event Free Survival (EFS) of untreated AML patients aged more than 65 years, treated with induction and consolidation chemotherapy courses, in one arm or with the same chemotherapy courses combined with ATRA in the other arm. The primary objective of the second randomization (R2) is to assess the benefit in terms of Relapse Free Interval (RFI) of maintenance with azacitidine in AML patients in CR, after induction and 4 to 6 consolidation courses of chemotherapy +/- ATRA.
Phase II multicentre clinical study with early treatment intensification in pts with high-risk hodgkin lymphoma, identified as FDG-PET scan positive after two conventional ABDVD courses
Jun 2008Main objective of the trial is to assess the 3years PFS
A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).
May 2008To determine the efficacy of oral eltrombopag, when administered once daily, for 6 months duration, to previously treated adult subjects with chronic ITP
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Apr 2008The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic leukemia or lymphoblastic lymphoma.
Retroviral Vector Mediated Globin Gene Transfer to Correct Sickle Cell Anemia or Thalassemia
Apr 2008Using sickle cell and thalassemia mouse models, researchers will evaluate the possibility of correcting these disorders by inserting healthy genetic material into the diseased blood cells.
Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia
Apr 2008The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.
Diffuse large B cell non-hodgkin's lymphoma in the vulnerable/frail elderly. A multicentrix randomized phase II trial with emphasis on geritaric assesment and quality of life.
Apr 2008The principal objective of the trial is to assess the therapeutic efficacy (in terms of complete remission at 6 month, as defined by Cheson et al. 1999) and the safety of R-COP and R-COPY in vulnerable/frail elderly patients with diffuse large B cell non-Hodgkin’s lymphoma.
Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
Mar 2008This clinical trial is studying how well an autologous stem cell transplant works in treating patients with acute myeloid leukemia.
A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia
Feb 2008To determine if a subcutaneous dosing schedule of veltuzumab can be established in NHL or CLL paitent and to confirm safety and efficacy of veltuzumab that was previously established when administered intravenously.
Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study)
Feb 2008This study will evaluate the safety and effectiveness of granulocyte transfusions in treating people with a bacterial or fungal infection during neutropenia
Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia
Feb 2008To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML.
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (UPCC 04407)
Feb 2008The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Jan 2008Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia or High-Risk Myelodysplastic Syndrome
Jan 2008This phase II trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation and donor bone marrow transplant and to see how well they work in treating patients with advanced acute myeloid leukemia or acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
A Combination of Imatinib Mesylate and Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia (UMCC 2006-128)
Dec 2007A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations: A Combination of Imatinib Mesylate & Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia.
High-dose sequential chemotherapy and rituximab (R-HDS) in HIV+ patients with non-hodgkin lymphoma (NHL) refractory or relapsed after 1st line treatment
Dec 2007To assess incidence of infectious complications and mortality after R-HDS in HIV+ patients
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects With Fever and Neutropenia
Nov 2007To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin in subjects with fever and neutropenia with regard to clinical cure versus not cured, after completing the initial course of therapy, without modification.
Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma
Oct 2007To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL.
Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit on Current START Protocols: Long Term Safety and Efficacy Analysis.
Oct 2007The primary objective is to determine the long term safety and tolerability of dasatinib. The secondary objective of this study is to collect long term efficacy in terms of molecular response.
Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin
Oct 2007To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with Ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent.
PPIP (Platelet Process Improvement Project): Comparison of platelets stored for 2-5 days versus platelets stored for 6-7 days in preventing and treating haemorrhage in thrombocytopenic patients – a randomised controlled trial
Sep 2007This study aims to show that platelets that have been stored for longer work just as well at preventing and stopping bleeding as platelets stored for up to 5 days.
Phase ll study evaluating the toxicity and efficacy of a modified German Paediatric Hodgkin's Lymphoma protocol (HD95) in young adults (aged 18-30 years) with Hodgkin's Lymphoma
Sep 2007Main objective of this study is to determine whether young adults (18-30 years) can receive modified HD95 therapy without experiencing excessive neurotoxicity due to the intensive use of Vinca alkaloids in this regimen.
A Phase I/II open label study to assess efficacy and safety of IPH1101 associated with low dose of interleukin 2, as add-on therapy to imatinib in CML patients with residual molecular disease
Aug 2007The primary objective is to assess the efficacy of IPH1101 associated with low dose of IL-2 as add-on therapy to imatinib in CML patients with residual molecular disease after at least 2 years of imatinib monotherapy.
A Phase II multicenter study to assess the tolerability and efficacy of the addition of Bevacizumab to standard induction therapy in AML and high risk MDS above 60 years.
Aug 2007The main objectives of this study are: to assess the safety and tolerability of bevacizumab added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and to assess in a randomized comparison the effect of bevacizumab on the CR rate.
Efficiency and tolerance study of methylprednisolone on the fall of platelets complicating preeclampsia - Multicentric, prospective, controlled, randomised, double blind, versus placebo, with individual benefit biomedical trial
Jul 2007To demonstrate efficiency of early treatment with methylprednisolone in order to reduce the fall of platelets during preeclampsia complicated of thrombocytopenia
Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)
Jul 2007Previous studies shows that risk of relapse is higher in patients treated with ATO postremission in monotherapy , than in other that receive ATO plus chemotherapy or transplantation (TPH). Also, compared with chemotherapy, ATO induction and consolidation has a favorable impact in posterior response to transplantation. It is due to a low toxicity or a best quality of remission to TPH. It seems better, for these reasons, the intensification with TPH (autologous or allogenic) in patients with relapsed APL treated with ATO. For another hand, patients no candidates to TPH can be treated with ATO combined with other active agents in APL, as ATRA, anthracyclines o Mylotarg
Fatigue and Symptom Burden in Febrile Neutropenia
Jul 2007To determine whether fatigue improves as patients are treated for febrile neutropenia (
Outpatients high-dose chemotherapy supported by autologus peripheral blood stem and single-dose pegfilgrastim in patients with lymphoproliferative malignances.
Jul 2007evaluation of mortality due to febrile neutropenia; evaluation of incidence of febrile neutropenia; percentage of readmissions to the hospital due to febrile neutropenia
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Jun 2007The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.
An open label phase II study to evaluate the efficacy and safety of induction and consolidation therapy with dasatinib in combination with chemotherapy in patients aged 55 years and over with philadelphia chromosome positive (PH+ or BCR-ABL+) acute lymphoblastic leukemia (ALL).
Jun 2007To evaluate the efficacy of a dasatinib-based induction and consolidation therapy
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma
May 2007This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) who have failed or are intolerant to tyrosine kinase inhibitor therapy
May 2007To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy.
A Phase III randomised, multicentre, double-blind, therapeutic equivalence study of biosimilar G-CSF (PLIVA/Mayne filgrastim) versus Neupogen (filgrastim-Amgen) in subjects receiving doxorubicin and docetaxel as a combination chemotherapy for breast cancer
May 2007To demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim to Neupogen.
The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) in early chronic phase: a Phase II exploratory, multicenter study
May 2007To investigate the cytogenetic and molecular effects of the protein tyrosine kinase (PTK) inhibitor nilotinib in the treatment of early chronic phase Ph+ CML.
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENESTnd)
May 2007In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
A randomised trial to compare ASPIRIN versus HYDROXYUREA/ASPIRIN in 'intermediate risk' primary thrombocythaemia and ASPIRIN only with observation in 'Low risk' primary thrombocythaemia.
Apr 2007In low risk patients (aged > or = 18 years and < 40 years) : What is the incidence of thrombosis and major haemorrhage while receiving aspirin only? In intermediate risk patients (aged 40-59 years) : Does hydroxyurea reduce thrombosis and major haemorrhage when added to aspirin? What is the effect of the treatment modalities on quality of life?
Phase II Multicenter Study Of P210-B3A2 Derived Peptide Vaccine In Chronic Myeloid Leukemia Patients In Complete Cytogenetic Response With Persistent Molecular Residual Disease During Imatinib Treatment
Apr 2007The primary objective of the trial is to evaluate the activity of p210-derived peptides vaccinations in terms of BCR-ABL/ ABL ratio reduction at 6 months from the starting of the vaccination program.
Phase II/III Randomized Study of Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Mar 2007Primary (patients considered fit for intensive treatment) Objectives: Compare the efficacy and toxicity of daunorubicin hydrochloride and cytarabine (DA) vs daunorubicin hydrochloride and clofarabine (DClo) as induction therapy in older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. Assess the value of gemtuzumab ozogamicin when given in combination with DA or DClo during course 1 of induction therapy. Compare a total of two vs three courses of treatment in patients who achieve at least partial remission (< 15% blasts) after course 1 of induction therapy. Compare the use of demethylation maintenance therapy comprising azacitidine vs no maintenance therapy in these patients. Assess the value of reduced-intensity allogeneic stem cell transplantation as consolidation in patients with matched donors.
An extension to a phase II open label study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis
Mar 2007The objective of this study is to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome positive chronic myeloid leukemia in myeloid blast crisis.
A Phase II Study Of Velcade Bortezomib - PS341 In The Treatment Of Patients Over 18 Years With Ph Leukemia
Feb 2007The objective of this study is to assess the efficacy and safety of Velcade Bortezomib - PS341 tn the treatment of patients over 18 Years with Ph leukemia.
A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Jan 2007To evaluate the efficacy of MK-0457, as defined by major cytogenetic response in chronic phase CML and as major hematological response in accelerated phase CML, blastic phase CML, and Ph+-ALL, when given as a 5-day CIV infusion every 14 days. To evaluate the safety of MK-0457 with this dose and regimen.
Timed-Sequential Induction in CBF-AML
Jan 2007The primary purpose of the protocol is to compare two modalities of timed-sequential induction in order to improve the results of the treatment of CBF-AML patients. This protocol also includes the biological characterization of the heterogeneity of these diseases (gene mutation and transcription profiles), as well as a centralized minimal residual disease monitoring and centralized evaluation of pharmacogenetic polymorphisms.
Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
Jan 2007The aim of the proposed study is to assess endothelial function and IMT, as correlates of cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.
A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
Jan 2007To assess the hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate
Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia
Jan 2007To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.
Clinical study to evaluate the efficacity and safety of octagam® 10% in idiopathic thrombocytopenic purpura in adults
Dec 2006To investigate the efficacity of Octagam® 10% in correcting the platelet count.
Stem Cell Transplant in Sickle Cell Disease and Thalassemia
Dec 2006The primary purpose of this study is to see if giving lower doses of chemotherapy (moderately ablative) will result in successful bone marrow replacement without as severe side-effects but with permanent control of the disease.
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
Dec 2006Primary objectives: To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL. To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse. To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.
Low dose rituximab in the treatment of autoimmune thrombocytopenia.
Dec 2006To assess overall and complete responses.
The Effect of Treating Patients with Anaemia in Diabetic Nephropathy to different target haemoglobin levels with Epoetin Beta
Nov 2006To determine whether treating patients with Anaemia and Diabetic Nephropathy with EPOETIN BETA to different target haemoglobin ranges has an effect on rate of deterioration of renal function, need for dialysis and death.
N-Acetylcysteine for Treatment of Sickle Cell Disease
Nov 2006To determine whether NAC therapy results in decreased red cell phosphatidylserine exposure, endothelial activation, inflammation, and reduction clotting activation in the steady state.
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)
Oct 2006To evaluate the safety and efficacy of the subcutaneous administration of homoharringtonine (HHT) in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML). Secondary endpoints include duration of treatment response, survival, induction mortality and hospitalizations.
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)
Oct 2006To evaluate the safety and efficacy of the subcutaneous administration of homoharringtonine (HHT) in the treatment of patients with refractory or relapsed acute myeloid leukemia (AML)
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL Gene Mutation
Sep 2006To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have the T315I BCR-ABL gene mutation.
Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation
Sep 2006To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.
A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma
Apr 2006Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131 Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from testing done on blood samples drawn at 12 timepoints over the first 7 days following administration of the dosimetric dose. Whole body gamma camera images will be obtained on six days following the dosimetric dose. Organ and tumor dosimetry data will be generated from gamma camera counts of specific organs and tumor. All scans will be examined by an independent review panel to evaluate biodistribution of the radionuclide.
A randomized two-by-two, multi-center, open-label phase 3 study of BMS-354825
Jul 2005The primary objective of this study was to compare the major cytogenetic response
Advert for Healthcare Professionals only