Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 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 core-binding factor acute myeloid leukemia
详细描述
The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
- •In status of complete remission after one to two courses of induction therapy
- •Total bilirubinic acid ≤ 35μmol/L, AST/ALT<2 times abnormal level, serum creatinine < 1.5mg/ml
- •Cardiac function: EF ≥ 50%
- •Hydroxyurea can be used for patient with white blood cell count ≥ 50*109/L
- •ECOG (Eastern Cooperative Oncology Group) score: ≤ 2
排除标准
- •Relapsed/refractory AML
- •Serious liver/ kidney dysfunction
- •Cardiac function level: 2 above
- •Female in pregnancy or lactation
- •With serious infection diseases or other diseases
- •Not obey the principle of clinical study
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 1500mg/m2/d for 5 days intravenously.
干预措施: Fludarabine (Drug)
high-dose cytarabine
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
Comparing the percentage of participants with disease recurrence with two therapeutic regimen
次要结局
- Percentage of Participants in survival(one year)
研究者
Xianmin Song, MD
professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine