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Belumosudil for Preventing Graft-Versus-Host Disease After Stem Cell Transplant

This study is looking at whether adding belumosudil, an oral medication, to the usual care can help prevent graft-versus-host disease (GVHD) in people with blood cancer who are having a stem cell transplant. GVHD is a serious complication where the new immune cells attack the patient's body. The study will also check the safety of this approach. You might be able to join if you are at least 18 years old, have a blood cancer that is in remission, and are having a stem cell transplant from a matched donor. The main goal is to see how many people are free from GVHD or cancer relapse one year after their transplant. The current recruitment status is unclear.

Study design
This study plans to enroll 46 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year after their stem cell transplant to assess GVHD/relapse-free survival.

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

NCT07006506

A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~46 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Belumosudil

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)
Measured over 1 year

Conditions

Graft Versus Host Disease
Graft Vs Host Disease
Hematologic Malignancy

Explore related trials

Graft Versus Host DiseaseMalignant neoplasm of lymphoid, hematopoietic and/or related tissue

Where it's being run

8 sites across 2 states
New York5
New Jersey3

Study leadership

  • Doris Ponce, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Doris Ponce, MD
[email protected]
646-608-3739
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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.
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.

Exclusion

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.
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.

What this trial measures

  • Change in GVHD/relapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)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.