A Prospective, Multicenter, Single Arm Clinical Study to Evaluate Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- event free survival
研究概览
简要总结
Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia （CEBPAdm AML）has favourite prognosis, especially in younger adult patients. But cumulative incidence of relapse of this group patients is still high, so the treatment options need to be optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.
详细描述
In this phase 2 study, 40 patients will be enrolled and treated with HAD induction regimen. High dose cytarabine will be given after complete remission achieved. The primary endpoint was event-free and relapse-free survival. Genetic mutations and measurable residual disease (MRD) will be detected at diagnosis and after chemotherapy. The risk stratification according to genetic mutations and MRD will also be explored.
induction chemotherapy:HHT 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4；1g/m2 /q12h ，day5-7 DNR 40mg/m2/d，day 1-3 re-induction chemotherapy:IDA 10mg/m2，day 1-3 cytarabine 100mg/m2，day 1-7 CTX 350mg/m2，day 2，day 5 consolidation chemotherapy: high dose cytarabine 3g/m2/Q12h,day1-3,for three cycles
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
- 14 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia
- •with CEBPA double mutation
- •age≥ 14 years and<55 years，male or female
- •ECOG-PS score 0-2
- •laboratory tests（within 7 days before chemotherapy）
- •serum total bilirubin≤1.5xULN；
- •serum AST and ALT≤2.5xULN
- •serum creatinine≤2xULN；
- •cardiac enzymes≤2xULN
- •ejection fraction >50% by ECHO。
- •written informed consent。
排除标准
- •subject has received remission induction chemotherapy
- •secondary AML
- •with other hematological malignancy
- •with other tumors(needing treatment)
- •pregnant or lactating women
- •active heart diseases
- •severe active infection
- •unfit for enrollment evaluated by investigator
研究组 & 干预措施
treatment arm
prospective, open-label, multicenter,single arm
干预措施: HAD induction with intermediate dose cytarabine (Drug)
结局指标
主要结局
event free survival
时间窗: 5 years
Measured from day 1 of randomization to the date of treatment failure, hematologic relapse from CR or death from any cause, whichever occurs first
relapse free survival
时间窗: 5 years
survival from complete remission to relapse
次要结局
- overall survival(5 years)
- complete remission rate(2.5 years)
- RFS cencored at stem cell transplantation(5 years)
- early mortality(2.5 years)