drugset / Trial / NCT07808112
CSF-1R Inhibitor, Axatilimab, for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, multisite, Phase II study designed to compare the 1-year GVHD-free survival of the control arm (no axatilimab) to the experimental arm (axatilimab) after myeloablative allogeneic HCT.
Timeline
- Start
- 2026-11
- Primary completion
- 2031-11
- Completion
- 2031-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axatilimab | Monoclonal antibody | 0.2 mg/kg | — |
| Subject | Axatilimab | Monoclonal antibody | 0.3 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | — | — |