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Phase 2 Study of Low-Dose Cyclophosphamide for GVHD Prevention

This study is testing a lower dose of cyclophosphamide (25 mg/kg) after an allogeneic stem cell transplant to prevent Graft-versus-Host Disease (GVHD). GVHD is a complication where the new immune cells attack your body. This study is for adults aged 18 and older with certain blood cancers, like acute leukemia, who are having a stem cell transplant. Researchers want to see if this lower dose of cyclophosphamide works as well as higher doses but with fewer side effects. Success for this study means fewer people get severe GVHD, chronic GVHD needing treatment, or their cancer comes back within one year. The current recruitment status is unclear, and the study plans to enroll 41 participants.

Study design
This is a Phase 2, single-arm, open-label study, meaning all participants receive the same treatment, and both you and your doctors will know what treatment you are getting. It plans to enroll 41 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for at least one year after their transplant to check for GVHD and cancer relapse.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06926595

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Milton S. Hershey Medical Center
~41 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Cyclophosphamide (primary intervention for GVHD prophylaxis)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Subjects Without Grade III/IV Acute Graft-Versus-Host Disease (GVHD) at 1 Year
Measured over 1 year post-transplant
+2 more outcomes measured

Conditions

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

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Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Joseph Cioccio, MD · PRINCIPAL_INVESTIGATOR · Penn State Cancer Institute

Who to contact

Crystal Sowers
[email protected]
7175315471
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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:
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

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.

What this trial measures

  • Number of Subjects Without Grade III/IV Acute Graft-Versus-Host Disease (GVHD) at 1 Year1 year post-transplant

    The number of subjects without Grade III/IV acute graft-versus-host disease (GVHD) at one year following allogeneic stem cell transplantation, assessed using the Modified Glucksberg Criteria (Grade III: severe organ involvement, e.g., skin stage 3-4, liver or gut stage 2-3; Grade IV: life-threatening dysfunction, e.g., skin, liver, or gut stage 4).

  • Number of Subjects Without Chronic Graft-Versus-Host Disease (GVHD) Requiring Systemic Treatment at 1 Year1 year post-transplant

    The number of subjects without chronic graft-versus-host disease (GVHD) requiring systemic treatment (e.g., corticosteroids or immunosuppressive therapy) at one year following allogeneic stem cell transplantation with low-dose post-transplant cyclophosphamide (25 mg/kg), assessed per the NIH Consensus Criteria for chronic GVHD.

  • Number of Subjects Without Relapse or Disease Progression at 1 Year1 year post-transplant

    The number of subjects without relapse or disease progression at one year following allogeneic stem cell transplantation, defined as the reappearance of the underlying disease or worsening of disease burden, assessed by standard clinical and laboratory measures (e.g., bone marrow biopsy, or disease-specific markers such as minimal residual disease \[MRD\] testing) per the study protocol.