Actively Recruiting
Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
Led by Milton S. Hershey Medical Center · Updated on 2026-04-03
41
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older at the time of study enrollment
- Diagnosis of 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 bone marrow
- Measurable residual disease detected by flow cytometry, PCR, or next generation sequencing is permitted
- Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in bone marrow
- Diagnosis of secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease, or overlap syndrome
- Diagnosis of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma indicated for allogeneic stem cell transplantation
- Diagnosis of lymphoma indicated for allogeneic stem cell transplantation, including follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T cell lymphomas, and Richter's transformation
- Planned reduced intensity or non-myeloablative conditioning regimen
- Have a related or unrelated peripheral blood stem cell donor meeting HLA matching and age criteria
- Cardiac ejection fraction of at least 40%
- Pulmonary function with FEV1 at least 50% predicted and DLCO corrected for hemoglobin at least 40% predicted
- Karnofsky performance status at least 70%
- Women of childbearing potential must have a negative serum pregnancy test before conditioning and agree to use two effective contraception methods or abstain from heterosexual intercourse through 12 months post-transplant
- Male patients with partners of childbearing potential must agree to effective barrier contraception or abstinence through 12 months post-transplant
You will not qualify if you...
- Prior allogeneic stem cell transplant
- Active central nervous system involvement by malignant cells
- Uncontrolled bacterial, viral, or fungal infections without clinical improvement
- Detectable viral load of HIV, hepatitis B, or hepatitis C (except patients with hepatitis B surface antibody positive due to vaccination or natural immunity, or those with sustained virologic remission from hepatitis C treatment)
- Myocardial infarction within 6 months, advanced heart failure (NYHA class III-IV), uncontrolled angina, severe ventricular arrhythmias, or acute ischemia on ECG
- Pregnant or lactating females (unless formula feeding)
- Serious medical or psychiatric illness likely to interfere with study participation
- Use of investigational agents
- Haploidentical related recipients positive for donor-specific antibodies with MFI ≥ 5000
- Steroid dose greater than 10 mg/day within one week of registration
- Autoimmune disorders requiring active immunosuppression therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
C
Crystal Sowers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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