A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg/kg) Versus Standard Dose (50mg/kg) Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin as Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- 100-day II-IV acute GVHD
研究概览
简要总结
This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.
详细描述
This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
- •normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);
- •Life expectation ≥3 months;
- •Informed consent provided.
排除标准
- •Pregnancies
- •active hepatitis (HBV-DNA≥1×103 copies/ml);
- •active infection require anti-biotics;
- •HIV infection
研究组 & 干预措施
Reduced dose of post-transplantation cyclophosphamide
study group
干预措施: reduced-dose PTCy (Drug)
Standard-dose PTCy
Patients receiving standard dose of post-transplantation cyclophosphamide
干预措施: Standard dose PTCY (Drug)
结局指标
主要结局
100-day II-IV acute GVHD
时间窗: 100 day
Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT
次要结局
- 100-day acute GVHD(100 day)
- 100-day non-relapse mortality(100 day)
- 1-year chronic GVHD(1 year)
- 1-year moderate to severe chronic GVHD(1 year)
- 1-year NRM(1 year)
- 1-year cumulated incidence of relapse(1 year)
- 1-year overall survival(1 year)
- 1-year graft host disease free and relapse free survival(1 year)
研究者
Jiong HU
Head, Blood & Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine