Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT
Summary
This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation. After obtaining written informed consent, participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged \<55 years) followed by unified post-transplant immunosuppression and supportive care. The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.
Timeline
- Start
- 2026-07-15
- Primary completion
- 2027-12-31
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |
| Subject | Semustine | Small molecule | 250 mg/m2 | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 2.5 mg/kg | — |