drugset / Trial / NCT03689465
PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis
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
Publications
- Background Wang Y, Fu HX, Liu DH, Xu LP, Zhang XH, Chang YJ, Chen YH, Wang FR, Sun YQ, Tang FF, Liu KY, Huang XJ. Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial. Bone Marrow Transplant. 2014 Mar;49(3):426-33. doi: 10.1038/bmt.2013.191. Epub 2013 Dec 2.
- Background Chang YJ, Huang XJ. Haploidentical SCT: the mechanisms underlying the crossing of HLA barriers. Bone Marrow Transplant. 2014 Jul;49(7):873-9. doi: 10.1038/bmt.2014.19. Epub 2014 Feb 24.
- Background Baron F, Mohty M, Blaise D, Socie G, Labopin M, Esteve J, Ciceri F, Giebel S, Gorin NC, Savani BN, Schmid C, Nagler A. Anti-thymocyte globulin as graft-versus-host disease prevention in the setting of allogeneic peripheral blood stem cell transplantation: a review from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation. Haematologica. 2017 Feb;102(2):224-234. doi: 10.3324/haematol.2016.148510. Epub 2016 Dec 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |