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Low-dose Post-transplant Cyclophosphamide for GVHD Prevention
NCT07319000Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2023
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Modality
- Small Molecules
- Drugs
- cyclophosphamide
- Conditions
- graft-versus-host disease (GVHD)
01
Overview
Phase 2, open-label, single-arm trial of cyclophosphamide in graft-versus-host disease (GVHD), sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Primary endpoint: Efficacy of Low-dose PT-Cy at 6 months. Started Jan 2023; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Low-dose post-transplant cyclophosphamide
Cyclophosphamide 30/mg/kg/day (allogeneic) or 40/mg/kg/day (haploidentical) for 2 continuous days.
03
Who it enrols
Adults with blood diseases requiring allogeneic bone marrow transplant, ECOG 0-2, and compatible related donors. Excludes patients with severe organ dysfunction, heart failure, renal failure, active infection, or pregnancy.
04
Endpoints
Primary
Efficacy of Low-dose PT-Cy
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