Data and safety monitoring board recommends continuation of Phase III trial of CPX 351 (cytarabine daunorubicin) liposome for injection (Vyxeos) in AML- Celator Pharmaceuticals
Celator Pharmaceuticals announced that the independent Data and Safety Monitoring Board for the company's Phase III clinical study of CPX 351 (cytarabine daunorubicin) liposome for injection (now referred to as Vyxeos) has completed the final pre-planned safety review of all patients and has again recommended the study continue as planned without any modifications.
The Phase III study compares Vyxeos versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (e.g. secondary) acute myeloid leukaemia (AML). The study (Protocol NCT01696084) enrolled 309 patients between the ages of 60 and 75 who have pathological diagnosis of high-risk AML. The primary endpoint for the study is overall survival, which the company expects to report in the first quarter of 2016.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins