A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia
试验速览
- 阶段
- 4 期
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of participants with disease recurrence
研究概览
简要总结
The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
- •In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
- •ECOG (Eastern Cooperative Oncology Group) score: <2
排除标准
- •Serious liver/ kidney dysfunction
- •Cardiac function level: 2 above
- •Female in pregnancy or lactation
- •With serious infection diseases or other diseases
研究组 & 干预措施
Fludarabine
The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
干预措施: Fludarabine (Drug)
Fludarabine
The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
干预措施: Cytarabine (Drug)
HD-Arac
The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
干预措施: Cytarabine (Drug)
结局指标
主要结局
Percentage of participants with disease recurrence
时间窗: one year
次要结局
- Percentage of Participants in survival(one year)
研究者
Xianmin Song
Associate Professor
Changhai Hospital