Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 9
- 主要终点
- disease-free survival
研究概览
简要总结
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
详细描述
Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR <10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.
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
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
- •myelodysplasia syndrome with bone marrow blast >5% and remaining less than 20% at transplantation
- •patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
- •inform consent provided
排除标准
- •AML patients with active CNS or extramedullary diseases
- •patients with active viral, bacterial or fungal infection
- •patients with hepatitis B virus >1X103 copy/ml
- •patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
- •patients with uncontrolled mental disorders
- •patients with HIV
研究组 & 干预措施
Flu-Bu2-Mel140
Patients receive fludarabine, busulfan and melphalan as conditioning regimen
干预措施: Fludarabine, busulfan and melphalan (Drug)
Flu-Bu4
Patients receive fludarabine and busulfan as conditioning regimen
干预措施: Fludarabine and Busulfan (Drug)
结局指标
主要结局
disease-free survival
时间窗: 2 year
event defined as relapse and death of any causes
次要结局
- overall survival(2 year)
- incidence of relapse(2 year)
- non relapse mortality(2 year)
研究者
Jiong HU
Head, Blood & Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine