Clinical Trial

Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention

Study acronym: GVHD-PTCy
Recruiting Phase 2
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Summary
This Phase 2, single-arm, open-label study aims to evaluate the safety and efficacy of low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) for prophylaxis of Graft-versus-Host Disease (GVHD) in patients undergoing allogeneic stem cell transplantation following reduced-intensity or non-myeloablative conditioning. The study will focus on matched sibling, matched unrelated, and haploidentical peripheral blood stem cell donors. The primary endpoint is 1-year GVHD-Free Relapse-Free Survival (GRFS). The study seeks to determine if low-dose PTCy offers similar outcomes as higher doses, with potentially reduced toxicity.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-10; most recent amendment 2026-03-30.
Status change: Not Yet Recruiting → Recruiting 2026-03-30
Trial Details
NCT Number NCT06926595
Lead Sponsor Milton S. Hershey Medical Center
Conditions Graft-versus-Host Disease (GVHD), Hematologic Malignancies, Allogeneic Stem Cell Transplantation
Enrollment 41 participants
Start Date 2026-03-09
Primary Completion 2030-11-01 (estimated)
Study Completion 2031-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-03