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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 2

Conditions

Hematologic Malignancy

Graft Vs Host Disease

Graft Versus Host Disease

Treatments

Drug: Belumosudil

Study type

Interventional

Funder types

Other

Identifiers

NCT07006506

25-033

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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.