drugset / Trial / NCT07677306

Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT

NCT07677306

Phase 2 Not yet recruiting 120 enrolled Peking University People's Hospital
NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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