A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
- Conditions
- Graft Versus Host DiseaseGraft Vs Host DiseaseHematologic Malignancy
- Interventions
- Registration Number
- NCT07006506
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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. The investigators will also look at the safety of the study approach.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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.
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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.
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Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.
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Karnofsky score ≥ 70%.
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Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)
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Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).
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Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
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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
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with hematologic malignancy in morphologic remission Belumosudil Participants will be diagnosed with a hematologic malignancy in morphologic remission
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
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