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

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06926595
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Allogeneic Stem Cell Transplantation
  • Graft-versus-Host Disease (GVHD)
  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide (primary intervention for GVHD prophylaxis) — DRUG
    This study evaluates the use of low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) for prophylaxis of Graft-versus-Host Disease (GVHD) following allogeneic stem cell transplantation. The intervention involves administering PTCy on days +3 and +4 post-transplant, in combination with tacrolimus and mycophenolate mofetil (MMF) for GVHD prevention. The goal is to assess the safety and efficacy of this regimen in patients undergoing reduced-intensity or non-myeloablative conditioning using peripheral blood stem cells from matched sibling, matched unrelated, and haploidentical donors

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Sep 2025
Primary completion
Nov 1, 2030
Completion
Nov 1, 2031

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Dose PTCy for GVHD Prophylaxis
    Participants in this single-arm study will receive low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) on days +3 and +4 following allogeneic hematopoietic stem cell transplantation. This will be administered in combination with tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis. The study includes patients receiving transplants from matched sibling, matched unrelated, single allelic mismatched unrelated, and haploidentical donors following reduced-intensity or non-myeloablative conditioning.

Primary Outcome Measure

Number of Subjects Without Grade III/IV Acute Graft-Versus-Host Disease (GVHD) at 1 Year [ Time Frame: 1 year post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Cancer InstituteHersheyPennsylvania17033

Find similar trials in Hershey, PA

By research site
Penn State Cancer Institute· Hershey, PA

Related Studies