drugset / Trial / NCT05921305
Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.
Timeline
- Start
- 2023-08-03
- Primary completion
- 2026-06-30
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MTX | Unknown | 5 mg/m2 | — |
| Comparator | Methylprednisolone | Other / unclassified | 0.2 mg/kg | — |
| Comparator | Prednisone | Other / unclassified | 0.25 mg/kg | — |