drugset / Trial / NCT01615757

Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation

NCT01615757 ↗

Phase 3 Unknown 180 enrolled All India Institute of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-08
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 2 mg/m2 Intravenous
Subject Cytarabine Small molecule 3 mg/m2 Intravenous