Graft Versus Host DiseasePhase 2NCT07006506
A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
A Phase 2 study testing Belumosudil in people with Graft Versus Host Disease and Graft Vs Host Disease, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease, Graft Vs Host Disease, Hematologic Malignancy
- What is being tested?
- Belumosudil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesUnited States
- Study dates
- 21 May 2025to 21 May 2029
- 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
- Patients ≥ 18 years-old at time of consent.
- Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).
- Recipients of 7-8/8 related or unrelated HLA-matched or related haploidentical donor.
- Peripheral blood stem cell graft
- Allo-HCT day <120 at time of consent
- Post-HCT inclusion criteria (within 3 weeks before start of belumosudil treatment)
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- Patient has received an allo-HCT transplant and is in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed.
- Patient has achieved engraftment. Engraftment is defined as ANC≥500/μL and platelets ≥ 20000/μL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.
- Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.
- Karnofsky score ≥ 70%.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)
- Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).
- Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
- Female subjects of childbearing potential (≤ 50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
- ° Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes: Intrauterine device (IUD) plus one barrier method Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or A vasectomized partner
- For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug.
Who cannot join
- Recipient of CD34+ selected or engineered stem cell graft.
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).
- Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Pulmonary dysfunction with DLCO <50% corrected for hemoglobin
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
- Post-HCT exclusion criteria
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- Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.
- Use of investigational agent within 14 days pre-HCT or anytime thereafter.
- Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).
- Active treatment with corticosteroids at a dose of ≥ 0.25 mg/kg/day for non-GVHD indication.
- Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
- Female patient who is pregnant or breastfeeding.
- Prior therapy with belumosudil.
- Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gajan Raju, MD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, 11725
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Doris Ponce, MD, 646-608-3739
- Recruiting
New York University (Data Collection Only)
New York, New York, 10010
Jingmei Hsi, MD, 646-501-4848
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Doris M Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Doris Ponce, MD, 646-608-3739
About this study
Official title: Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation
The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.
- Being tested
- Belumosudil
- Keywords
- Graft Versus Host Disease, Graft Vs Host Disease, Hematologic Malignancy, Hematologic malignancy in morphologic remission, Belumosudil, Stem Cell Transplant, Memorial Sloan Kettering Cancer Center, 25-033
- 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.
BelumosudilDrug
Belumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2)
| Study group | Role | What they receive |
|---|---|---|
| Participants with hematologic malignancy in morphologic remission | Experimental | Participants will be diagnosed with a hematologic malignancy in morphologic remission Receives: Drug: Belumosudil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)
The primary objective is to assess the efficacy of belumosudil in the improvement of GRFS at 1-year post-HCT for patients receiving PTCY GVHD prophylaxis and separately for participants receiving CNI-based (CNI without PTCY) plus abatacept GVHD prophylaxis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start21 May 2025
- Primary completion21 May 2029 (estimated)
- Study completion21 May 2029 (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 DiseaseStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doris Ponce, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006506
- Sponsor's protocol ID
- 25-033
- Status last verified
- Jun 2026
- First submitted
- 22 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT07006506
- Acronym / sponsor ID
- 25-033
- Keywords
- Graft Versus Host Disease, Graft Vs Host Disease, Hematologic Malignancy, Hematologic malignancy in morphologic remission, Belumosudil, Stem Cell Transplant, Memorial Sloan Kettering Cancer Center, 25-033
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 21 May 2029 (estimated)
- Study completion
- 21 May 2029 (estimated)
- First posted
- 5 Jun 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.
The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with hematologic malignancy in morphologic remission | Experimental | Drug: BelumosudilParticipants will be diagnosed with a hematologic malignancy in morphologic remission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients ≥ 18 years-old at time of consent.
- Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).
- Recipients of 7-8/8 related or unrelated HLA-matched or related haploidentical donor.
- Peripheral blood stem cell graft
- Allo-HCT day <120 at time of consent
Key exclusion criteria (14 listed)
- Recipient of CD34+ selected or engineered stem cell graft.
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).
- Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Pulmonary dysfunction with DLCO <50% corrected for hemoglobin
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
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 |
|---|---|---|
| BelumosudilBelumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2) | Drug | Participants with hematologic malignancy in morphologic remission |
Primary outcome
Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)
Time frame: 1 year
The primary objective is to assess the efficacy of belumosudil in the improvement of GRFS at 1-year post-HCT for patients receiving PTCY GVHD prophylaxis and separately for participants receiving CNI-based (CNI without PTCY) plus abatacept GVHD prophylaxis.
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 29 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Gajan Raju, MD contact
Doris Ponce, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belumosudil in people with Graft Versus Host Disease and Graft Vs Host Disease, run by Memorial Sloan Kettering Cancer Center at 8 sites 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 16 inclusion and 14 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Doris Ponce, MD (646-608-3739, ponced@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT) (time frame: 1 year). 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 29 Jun 2026.