RECRUITING

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

Conditions

Graft Versus Host Disease Graft Vs Host Disease Hematologic Malignancy Hematologic malignancy in morphologic remission Belumosudil Stem Cell Transplant Memorial Sloan Kettering Cancer Center 25-033

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation

Quick Facts

Study Start:2025-05-21

Study Completion:2029-05-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07006506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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.	* 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 * 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.

Inclusion Criteria

Exclusion 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
* 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.

* 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
* 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.

Contacts and Locations

Study Contact

Doris Ponce, MD

CONTACT

646-608-3739

ponced@mskcc.org

Miguel-Angel Perales, MD

CONTACT

646-608-4044

peralesm@MSKCC.ORG

Principal Investigator

Doris Ponce, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-21

Study Completion Date2029-05-21

Study Record Updates

Study Start Date2025-05-21

Study Completion Date2029-05-21

Terms related to this study

Keywords Provided by Researchers

Graft Versus Host Disease
Graft Vs Host Disease
Hematologic Malignancy
Hematologic malignancy in morphologic remission
Belumosudil
Stem Cell Transplant
Memorial Sloan Kettering Cancer Center
25-033

Additional Relevant MeSH Terms

Graft Versus Host Disease
Graft Vs Host Disease
Hematologic Malignancy