A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years.
详细描述
the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.
High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose，but it is not determined in Chinese older adult AML patients.
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
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary AML（except APL patients）;
- •ECOG PS:0-2
排除标准
- •AML patient who has already received induction treatment, no matter what the outcome is;
- •Treatment-related AML;
- •Active cancer patients who's condition need to be treated;
- •The one with serious infectious diseases（eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis）
- •Active heart disease.
研究组 & 干预措施
escalated daunorubicin
Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
干预措施: Daunorubicin (Drug)
escalated daunorubicin
Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
干预措施: Cytarabine (Drug)
standard daunorubicin
Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
干预措施: Daunorubicin (Drug)
standard daunorubicin
Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
干预措施: Cytarabine (Drug)
medium dosage cytarabine
1g/m2 q12h for 3 days as consolidation therapy.
干预措施: Cytarabine (Drug)
standard dosage cytarabine
100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.
干预措施: Cytarabine (Drug)
结局指标
主要结局
overall survival
时间窗: 3 years
次要结局
- complete remission rate(2 months)
- relapse free survival(3 years)
- complete remission rate in different risk group(2 month)
- treatment-related mortality(2 months)
研究者
Jianxiang Wang
vise-president
Chinese Academy of Medical Sciences