drugset / Trial / NCT02876679
Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT
RandomizedParallel-groupOpen-labelPrevention
Summary
The study is designed as a two arm randomized Phase II, multicenter trial comparing cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis in patients with hematologic malignancies undergoing reduced intensity conditioning hematopoietic stem cell transplantation.
Timeline
- Start
- 2017-04-06
- Primary completion
- 2020-10-12
- Completion
- 2020-10-12
Publications
- Brissot E, Labopin M, Labussiere H, Fossard G, Chevallier P, Guillaume T, Yakoub-Agha I, Srour M, Bulabois CE, Huynh A, Chantepie S, Menard AL, Rubio MT, Ceballos P, Dulery R, Furst S, Malard F, Blaise D, Mohty M. Post-transplant cyclophosphamide versus anti-thymocyte globulin after reduced intensity peripheral blood allogeneic cell transplantation in recipients of matched sibling or 10/10 HLA matched unrelated donors: final analysis of a randomized, open-label, multicenter, phase 2 trial. Blood Cancer J. 2024 Feb 19;14(1):31. doi: 10.1038/s41408-024-00990-3.
- Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2.5 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Background | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Background | Cyclosporine | Peptide | — | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |