Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Milton S. Hershey Medical Center
You may qualify if…
- ✓ Age 18 or older at the time of study enrollment.
- ✓ Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow.
- ✓ Flow cytometric, polymerase chain reaction (PCR) or next generation sequencing (NGS) detected measurable residual disease is permitted.
- ✓ Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with \<5% vs 5-10% blasts in this disease).
- ✓ Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN overlap syndrome.
- ✓ Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.
- ✓ Patients with lymphoma who are indicated for allogeneic stem cell transplantation, including follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma (including primary mediastinal B cell lymphoma), mantle cell lymphoma, peripheral T cell lymphomas, and Richter's transformation.
- ✓ Planned reduced intensity or non-myeloablative conditioning regimen.
You may not qualify if…
- ✕ Prior allogeneic stem cell transplant.
- ✕ Active central nervous system (CNS) involvement by malignant cells.
- ✕ Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).
- ✕ Seropositive for human immunodeficiency virus (HIV) with detectable viral load, hepatitis B virus (HBV) or hepatitis C virus (HCV) with detectable viral load. Hepatitis B surface antibody positive due to vaccination or natural immunity are permitted. Patients previously treated for HCV and considered to be in sustained virologic remission (SVR) are allowed.
- ✕ Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
- ✕ Pregnant or lactating female patients (unless feeding via formula). Women of childbearing potential (WOCBP) are required to have a negative serum or urine pregnancy test prior to conditioning regimen.
- ✕ Serious medical or psychiatric illness likely to interfere with participation in the study.
- ✕ Use of investigational agents.
Where it's recruiting
Hershey
Source: ClinicalTrials.gov · NCT06926595 · last updated 2026-04-03