NCT06926595 Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
| NCT ID | NCT06926595 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Graft-versus-Host Disease (GVHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2030-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 41 participants in total. It began in 2026-03-09 with a primary completion date of 2030-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. * Patients must have a related or unrelated peripheral blood stem cell donor as follows: Sibling donor must be at least haploidentical using high resolution DNA-based HLA typing. Children or parent donor must be at least haploidentical using high resolution DNA-based HLA typing. Children donors must be at least 18 years of age at the time of evaluation. Unrelated donors must be a 7/8 or 8/8 match at HLA-A, B, C, and DRB1 at high resolution using DNA based typing. * Cardiac function: must demonstrate at ejection fraction of at least 40%. * Pulmonary function: must have FEV1 of at least 50% predicted, and DLCO corrected for hemoglobin of at least 40% predicted. * Karnofsky performance status at least 70%. * Women of childbearing potential (WOCP), defined as not surgically sterile (hysterectomy, tubal ligation, or oophorectomy) or at least 1 year postmenopausal, must have a negative serum pregnancy test before conditioning regimen. * Female patients (unless post-menopausal or surgically sterilized) must agree to practice two effective methods of contraception simultaneously or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 12 months post-transplant. * Male patients (even if surgically sterilized) who are partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant. Exclusion Criteria: * 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. * Haploidentical related recipient who are positive for DSA ≥ 5000 MFI by solid phase microarray method (Luminex). * Any patient with steroid dose more than 10 mg/day within a week of registration. * Autoimmune disorder requiring any active immunosuppression therapy.
Contact & Investigator
Joseph Cioccio, MD
PRINCIPAL INVESTIGATOR
Penn State Cancer Institute
Frequently Asked Questions
Who can join the NCT06926595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Graft-versus-Host Disease (GVHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06926595 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06926595 currently recruiting?
Yes, NCT06926595 is actively recruiting participants. Contact the research team at psci-cto@pennstatehealth.psu.edu for enrollment information.
Where is the NCT06926595 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT06926595 clinical trial?
NCT06926595 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Joseph Cioccio, MD at Penn State Cancer Institute. The trial plans to enroll 41 participants.