drugset / Trial / NCT03689465

PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

NCT03689465

Phase 4 Unknown 260 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupOpen-labelPrevention

Summary

The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.

Timeline

Start
2018-10-29
Primary completion
2020-09-30
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 4.5 mg/kg Intravenous
Comparator ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 7.5 mg/kg Intravenous
Comparator Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Comparator Methotrexate Small molecule Intravenous
Comparator Cyclosporine Peptide 2.5 mg/kg Intravenous
Comparator Mycophenolate Mofetil Small molecule 0.25 g Oral