RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 84
- 主要终点
- complete remission (CR) rate
研究概览
简要总结
One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender with age ≤18 years at initial diagnosis
- •AML(non-M3) patients at first relapse (medullary)
排除标准
- •Primary refractory AML &secondary AML
- •More than or equal to 2 relapses of AML
- •Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
- •Active infection(pneumonia etc.)
- •Any other organ dysfunction (CTCAE Grade 4)
- •Patients not willing to consent for the study
研究组 & 干预措施
ADE arm
ADE arm
Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days
干预措施: ADE Protocol (Drug)
结局指标
主要结局
complete remission (CR) rate
时间窗: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR
次要结局
- Event free survival (EFS) and overall survival(OS)(2 year)
- toxicity of chemotherapy(Day 28 ± 7 of treatment)
- clonal evolution(Day 28 ± 7 of treatment)
- minimal residual disease (MRD)(Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier)
- cardiac function(Day 28 ± 7 of treatment)
研究者
ARUN GARG, MD, DM
SENIOR RESIDENT
All India Institute of Medical Sciences, New Delhi