drugset / Trial / NCT04203108

ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis

NCT04203108

Phase 4 Unknown 266 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

The protocols including ciclosporin A (CsA)+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.

Timeline

Start
2019-09-01
Primary completion
2021-08-31
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 2.5 mg/kg Intravenous
Background Cyclosporine Peptide Intravenous
Background Methotrexate Small molecule 10 mg Intravenous
Background Mycophenolate Mofetil Small molecule 1 g

Indications

No indication recorded.