drugset / Trial / NCT06069180

The Optimization of Conditioning Regimen for HLA Matched HSCT in SAA

NCT06069180

Phase 4 Unknown 160 enrolled Peking University People's Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Hematopoietic stem cell transplantation (HSCT) from a human leukocyte antigen (HLA) -matched donor is an effective option for severe aplastic anemia (SAA), but there is no standardized and recommended conditioning regimen. The occurrence of mixed chimerism after transplantation is associated with secondary graft failure and poor failure-free survival. Previous studies have shown that Fludarabine (Flu)/ Cyclophosphamide (Cy)/ antithymocyte globulin (antithymocyte globulin), ATG) and Cy/ATG conditioning regimens had higher rates of mixed chimerism and poorer failure-free survival. A small cohort study has suggested that adding busulfan to Flu/Cy/ATG or Cy/ATG can reduce the incidence of mixed chimerism and improve failure-free survival. This study was a prospective, multicenter, randomized controlled trial to compare the efficacy and safety of different conditioning regimens in the treatment of severe aplastic anemia (SAA) after hematopoietic stem cell transplantation (HSCT) from HLA-identical sibling or unrelated donor.

Timeline

Start
2023-11-15
Primary completion
2024-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic
Background Cyclophosphamide Other / unclassified
Background Fludarabine Small molecule

Indications