Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- disease-free survival (DFS)
研究概览
简要总结
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan
详细描述
For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
- •patients with HLA matched sibling, unrelated or Haplo-identical donor
排除标准
- •patients with active infection
- •patients with abnormal liver function damage: ALT/AST above 2X normal range
- •patients with abnormal renal function damage Scr>160µmol/L;
- •patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%)
- •patients with mental instability or unwilling to give inform consent
研究组 & 干预措施
Flu-Bu-Mel
Fludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2
干预措施: Flu-Bu-Mel (Drug)
结局指标
主要结局
disease-free survival (DFS)
时间窗: 1 year after transplantation
From transplantation to documentation of death or relapse or progression
次要结局
- Relapse rate(1 year after transplantation)
- relapse free survival (GRFS)(1 year after transplantation)
- non-relapse mortality (NRM)(1 year after transplantation)
- chronic graft versus host disease (cGVHD)(1 year after transplantation)
- Overall survival (OS)(1 year after transplantation)
- acute graft versus host disease (aGVHD)(day 180 after transplantation)
研究者
Jiong HU
Head, Blood & Marrow Transplantation Center
Shanghai Jiao Tong University School of Medicine