New drug combo aims to prevent transplant complications in blood cancer patients
NCT ID NCT07006506
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This study tests whether adding the drug belumosudil to standard care can better prevent graft-versus-host disease (GVHD) in adults with blood cancer who have had a stem cell transplant. About 46 participants will receive belumosudil along with their usual GVHD prevention medicines. The main goal is to see if this approach improves survival without GVHD or cancer relapse one year after transplant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * 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. Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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New York University (Data Collection Only)
RECRUITINGNew York, New York, 10010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Stem cell infusions put to the test against a tough transplant complication
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Can adding rituximab improve remission in chronic GVHD?