A Comparison Study of Reduced Dose of Post-transplantation Cyclophosphamide (PTCy 40mg/kg) Versus Standard (PTCY 50mg/kg): a Multi-center Study for Halo-identical Donor Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- acute GVHD (grade II-IV)
研究概览
简要总结
Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.
详细描述
Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg) was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our observation, in this study, a prospective multiple-center randomized comparison is planned to evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients with hematological malignancies
- •Patients undergo allogeneic stem cell transplantation from haplo-identical donors
- •Patents with informed consent provided
排除标准
- •Patients with active infection ()bacteria, fungal or viral)
- •Patients with liver, renal and cardiac dysfunction not suitable for undergoing allogeneic stem cell transplantation.
研究组 & 干预措施
PTCy-40
Patients receive 40mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.
干预措施: PTCY (Drug)
PTCy-50
Patients receive 50mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.
干预措施: PTCY (Drug)
结局指标
主要结局
acute GVHD (grade II-IV)
时间窗: day 100
clinical documentation of grade II-IV aGVHD
次要结局
- Non-relapse mortality(1 year)
- overall survival(1 year)
- Survival without relapse and moderate to severe GVHD(1 year)
- chronic GVHD(1 year)
- Disease-free survival(1 year)
研究者
Jiong HU
Deputy director, department of hematology
Shanghai Jiao Tong University School of Medicine