A Multiple-center Phase II Study to Evaluate the Clinical Outcome of Reduced Conditioning Regimen With Melphalan, Busulfan and Fludarabine for Patients >=55 Years With Myeloid Malignancies.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- disease-free survival
研究概览
简要总结
In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.
详细描述
Conditioning regimen with double alkylating agents such as busulfan + melphalan or Busulfan + thiotepa have been shown to improve the transplantation outcome in terms of lower relapse rate in various myeloid malignancies. In this multiple-center phase II study, the aim is to evaluate the clinical outcome of reduced intensity conditioning regimen with fludarabine (150mg/m2), busulfan (6.4mg/kg) and melphalan (100mg/m2) in patients with myeloid malignancies including AML, MDS and CMML >=55 years.
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
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55-65
- •patients with HLA-matched sibling donors, 9-10/10 matched unrelated donors or haplo-identical donors.
- •patients with AML in remission, or MDS in any stage, or CMML in any stage
- •inform consent provided
排除标准
- •patients with abnormal liver (>3N), renal (1.5N) or cardiac function
- •patients with active infection
研究组 & 干预措施
MBF-RIC
Patients with MBF-RIC as conditioning regimen
干预措施: MBF-RIC (Drug)
结局指标
主要结局
disease-free survival
时间窗: 2 year
survival without disease relapse or progression
次要结局
- overall survival(2 year)
- GVHD and relapse free survival(2 year)
- 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