Graft-versus-Host Disease (GVHD)Phase 2GVHD-PTCyNCT06926595
Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
A Phase 2 study testing Cyclophosphamide (primary intervention for GVHD prophylaxis) in people with Graft-versus-Host Disease (GVHD) and Hematologic Malignancies, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-versus-Host Disease (GVHD), Hematologic Malignancies, Allogeneic Stem Cell Transplantation
- What is being tested?
- Cyclophosphamide (primary intervention for GVHD prophylaxis)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 1 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
7175315471, PSCI-CTO@pennstatehealth.psu.edu
About this study
Official title: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies
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.
Read the detailed description
This study investigates the use of low-dose post-transplant cyclophosphamide (PTCy) for GVHD prophylaxis in a Phase 2, single-arm design. It involves patients receiving allogeneic stem cell transplantation with peripheral blood stem cells from matched sibling, matched unrelated, and haploidentical donors, following reduced-intensity or non-myeloablative conditioning. The aim is to evaluate 1-year GVHD-Free Relapse-Free Survival (GRFS) using 25 mg/kg of PTCy administered on days +3 and +4, in combination with tacrolimus and mycophenolate mofetil (MMF).
The study builds on previous research that has shown the effectiveness of PTCy in preventing GVHD in various transplant settings, including haploidentical and matched unrelated donors. Lower doses of PTCy, such as 25 mg/kg, have been shown to be effective in other settings with reduced toxicity compared to the standard 50 mg/kg dose, and this study will assess whether the same holds true for peripheral blood stem cell transplants.
The findings from this trial will help determine the optimal dosing strategy for PTCy in GVHD prophylaxis, with the potential to improve patient outcomes by minimizing toxicity while maintaining efficacy.
- Conditions
- Graft-versus-Host Disease (GVHD), Hematologic Malignancies, Allogeneic Stem Cell Transplantation
- Being tested
- Cyclophosphamide (primary intervention for GVHD prophylaxis)
- Medical subject headings
- Graft vs Host Disease, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide (primary intervention for GVHD prophylaxis)Drug
Also called Tacrolimus (part of the GVHD prophylaxis regimen), Mycophenolate mofetil (MMF) (part of the GVHD prophylaxis regimen)
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 group | Role | What they receive |
|---|---|---|
| Low-Dose PTCy for GVHD Prophylaxis | Experimental | 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. Receives: Drug: Cyclophosphamide (primary intervention for GVHD prophylaxis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Without Grade III/IV Acute Graft-Versus-Host Disease (GVHD) at 1 Year
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).
Measured: 1 year post-transplant
Number of Subjects Without Chronic Graft-Versus-Host Disease (GVHD) Requiring Systemic Treatment at 1 Year
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.
Measured: 1 year post-transplant
Number of Subjects Without Relapse or Disease Progression at 1 Year
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.
Measured: 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start9 Mar 2026
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-Host Disease (GVHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, Phase 2 clinical trial. All participants will receive the same intervention, which is low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) for GVHD prophylaxis, in combination with tacrolimus and mycophenolate mofetil (MMF). The study will assess the safety and efficacy of this regimen in patients undergoing allogeneic stem cell transplantation using peripheral blood stem cells from matched sibling, matched unrelated, and haploidentical donors, following reduced-intensity or non-myeloablative conditioning.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Cioccio, Milton S. Hershey Medical Center
- Investigators
- Joseph Cioccio, MD, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926595
- Sponsor's protocol ID
- PSCI-24-047
- Other IDs
- PSCI-24-047
- Acronym
- GVHD-PTCy
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies
- ClinicalTrials.gov ID
- NCT06926595
- Acronym / sponsor ID
- GVHD-PTCy / PSCI-24-047
- Conditions
- Graft-versus-Host Disease (GVHD), Hematologic Malignancies, Allogeneic Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study investigates the use of low-dose post-transplant cyclophosphamide (PTCy) for GVHD prophylaxis in a Phase 2, single-arm design. It involves patients receiving allogeneic stem cell transplantation with peripheral blood stem cells from matched sibling, matched unrelated, and haploidentical donors, following reduced-intensity or non-myeloablative conditioning. The aim is to evaluate 1-year GVHD-Free Relapse-Free Survival (GRFS) using 25 mg/kg of PTCy administered on days +3 and +4, in combination with tacrolimus and mycophenolate mofetil (MMF).
The study builds on previous research that has shown the effectiveness of PTCy in preventing GVHD in various transplant settings, including haploidentical and matched unrelated donors. Lower doses of PTCy, such as 25 mg/kg, have been shown to be effective in other settings with reduced toxicity compared to the standard 50 mg/kg dose, and this study will assess whether the same holds true for peripheral blood stem cell transplants.
The findings from this trial will help determine the optimal dosing strategy for PTCy in GVHD prophylaxis, with the potential to improve patient outcomes by minimizing toxicity while maintaining efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, Phase 2 clinical trial. All participants will receive the same intervention, which is low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) for GVHD prophylaxis, in combination with tacrolimus and mycophenolate mofetil (MMF). The study will assess the safety and efficacy of this regimen in patients undergoing allogeneic stem cell transplantation using peripheral blood stem cells from matched sibling, matched unrelated, and haploidentical donors, following reduced-intensity or non-myeloablative conditioning.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose PTCy for GVHD Prophylaxis | Experimental | Drug: Cyclophosphamide (primary intervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide (primary intervention for GVHD prophylaxis)Also: Tacrolimus (part of the GVHD prophylaxis regimen), Mycophenolate mofetil (MMF) (part of the GVHD prophylaxis regimen)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 | Drug | Low-Dose PTCy for GVHD Prophylaxis |
Primary outcome
Number of Subjects Without Grade III/IV Acute Graft-Versus-Host Disease (GVHD) at 1 Year
Time frame: 1 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 Year
Time frame: 1 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 Year
Time frame: 1 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. Study results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Cioccio, MD principal investigator
Penn State Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide (primary intervention for GVHD prophylaxis) in people with Graft-versus-Host Disease (GVHD) and Hematologic Malignancies, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Sowers (7175315471, psci-cto@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.