NCT06705062 Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation
| NCT ID | NCT06705062 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Allogeneic Hematopoietic Cell Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility Criteria
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