Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Comb
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
| Condition(s) | Allogeneic Hematopoietic Cell Transplant, Graft Versus Host Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor; 2. 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%); 3. ECOG: 0-2; 4. Life expectation ≥3 months; 5. Informed consent provided. Exclusion Criteria: 1. Pregnancies 2. active hepatitis (HBV-DNA≥1×103 copies/ml); 3. active infection require anti-biotics; 4. HIV infection |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Lead sponsor | Shanghai Jiao Tong University School of Medicine |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-01-01 |
| NCT ID | NCT06705062 |
| Official listing | https://clinicaltrials.gov/study/NCT06705062 |