Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- Event free survival
研究概览
简要总结
We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).
详细描述
Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML diagnosis,
- •treated with 3+7 Induction chemotherapy
- •Intermediate/standard risk AML
排除标准
- •Diagnosed of APL
- •high risk molecular/cytogenetic score
研究组 & 干预措施
No allogeneic SCT
For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan
干预措施: Prescribing conventional chemotherapy while with holding allo-SCT (Procedure)
Standard post induction therapy
For slow responding AML patients, post induction therapy will be provided according to treating physician discretion
干预措施: Prescribing conventional chemotherapy while with holding allo-SCT (Procedure)
结局指标
主要结局
Event free survival
时间窗: Two years
次要结局
- Overall survivial(two years)
研究者
Dr. Yishai Ofran
Director of leukemia Service
Rambam Health Care Campus