drugset / Trial / 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
Phase 3
Recruiting
316 enrolled
Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University Affiliated Sixth People's Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2025-01-01
- Primary completion
- 2027-12-01
- Completion
- 2028-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 35 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Background | Tacrolimus | Small molecule | — | — |
| Background | reduced-dose PTCy | Unknown | 2.5 mg/kg | — |