A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
NCT ID: NCT07006506
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2025-05-21
2029-05-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with hematologic malignancy in morphologic remission
Participants will be diagnosed with a hematologic malignancy in morphologic remission
Belumosudil
Belumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2)
Interventions
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Belumosudil
Belumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2)
Eligibility Criteria
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Inclusion Criteria
* 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.
° 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
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Doris Ponce, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Doris Ponce, MD
Role: primary
Doris Ponce, MD
Role: primary
Doris Ponce, MD
Role: primary
Doris Ponce, MD
Role: primary
Doris Ponce, MD
Role: primary
Doris M Ponce, MD
Role: primary
Doris Ponce, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-033
Identifier Type: -
Identifier Source: org_study_id