Data from Clinical Trials - Curated by EPG Health - Last updated 16 August 2017

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

purpose

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

Primary Outcome Measures:

  • Response to therapy (percentage of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). [ Time Frame: 6 months ]
  • Overall Survival [ Time Frame: Baseline to 24 months ]
 

Secondary Outcome Measures:

  • Progression free survival [ Time Frame: Baseline to 24 months ]
  • Volume of distribution (Vd) for inotuzumab ozogamicin in serum [ Time Frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8 ]
  • Systemic clearance (CL) for inotuzumab ozogamicin in serum [ Time Frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8 ]
  • Duration of response [ Time Frame: Baseline to 24 months ]
  • Rate of stem-cell transplantation: percentage of patients having stem-cell transplant [ Time Frame: Baseline to 8 months ]
  • Minimal residual disease (MRD): number of leukemic cells in bone marrow after CR/CRi [ Time Frame: Baseline to 7 months ]
  • Cytogenetics: quantitate t(9;22), MLL, and IGH rearrangements in leukemia cells [ Time Frame: Baseline to 7 months ]
  • Quality of life: . EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer. Quality of Life Questionnaire, Core-30 [ Time Frame: Baseline to 6 months ]
  • Quality of life: EQ-5D = EuroQual -5D Health Questionnaire [ Time Frame: Baseline to 6 months ]
Category Value
Date last updated at source 05-Jan-17
Recruiting in France, Taiwan, Australia, Japan, Hungary, Italy, Canada, Spain, Czech Republic, Sweden, Poland, Republic of Korea, United Kingdom, China, Finland, Argentina, United States of America, Singapore, Germany, Netherlands
Study type(s) Interventional
Expected enrolment 325
Study start date 01-Aug-12
Estimated primary completion date 01-Mar-16

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