drugset / Trial / NCT06000982
Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis
Phase 3
Unknown
138 enrolled
Shanghai Jiao Tong University School of Medicine
Shanghai Clinical Research Center · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2023-10-01
- Primary completion
- 2025-10-01
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 40 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |