Comparison of Ara-c 12 gm/m2 vs 18 gm/m2 Per Cycle for 3 Cycles Each as Consolidation in AML ; An Open Label Randomized Non-inferiority Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Relapse free survival at 1 yr of follow up
研究概览
简要总结
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.
详细描述
Objectives
- To compare the efficacy of two different doses of Cytarabine during consolidation therapy for newly diagnosed patients of Non APML - Acute Myeloid Leukemia who are in CR post induction
- To compare the toxicity of the two different Cytarabine doses
Primary end point
- Relapse free survival at 1 yr from randomization
- Relapse will be defined as >5 % leukemic blasts in the marrow aspirate or new extramedullary disease anytime after randomization
Secondary end points
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- •Suitable for HIDAC as consolidation
- •AML with underlying MDS will be included
排除标准
- •Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- •Concurrent active malignancy
- •HIV infection, Uncontrolled Hepatitis B/C
- •Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
- •Serum Bilirubin > 2
- •Delayed recovery of blood counts /persistent active infection > 45 days from start of induction
- •Patients receiving reinduction with HIDAC
- •Therapy related AML
研究组 & 干预措施
Arm B, Ara-c - 12 gm/m2
Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5
干预措施: Ara-c (Drug)
Arm A. Ara-c 18 gm/m2
Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5
干预措施: Ara-c (Drug)
结局指标
主要结局
Relapse free survival at 1 yr of follow up
时间窗: 1 year
次要结局
- Toxicity- Haematological and Non -Haematological(at 1 yr)
研究者
Prashant Mehta
Senior Resident , Department of Medical Oncology
All India Institute of Medical Sciences, New Delhi