Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation
Status:
Unknown status
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The study will be conducted in the Department of Medical Oncology and Department of
Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in
complete remission after induction chemotherapy will be enrolled into the study and will be
further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3
cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study
protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the
relapse free survival and overall survival as well as time to relapse and toxicity /treatment
related morbidity.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi