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

Study acronym: GVHD-PTCy
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2030 to Nov 1, 2030
    • Study completion date: Oct 1, 2031 to Nov 1, 2031
    • Start date changed from estimate of Feb 1, 2026 to Mar 9, 2026
    • Site details revised
  2. Start date: Nov 1, 2025 to Feb 1, 2026
    • Primary completion date: Aug 1, 2030 to Oct 1, 2030
    • Study completion date: Aug 1, 2031 to Oct 1, 2031
    v3
  3. Start date: Aug 1, 2025 to Nov 1, 2025
    • Site contact updated
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06926595
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)		 Graft-versus-Host Disease (GVHD), Hematologic Malignancies, Allogeneic Stem Cell Transplantation
Related terms Graft vs Host Disease, Hematologic Neoplasms
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov