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Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

NCT06046248 · Northside Hospital, Inc.
In plain English

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Official title
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
About this study
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
Eligibility criteria
Inclusion Criteria: * First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD) * Previously untreated, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD * KPS \>/= 70% * Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC \>750 cells/mm3; Platelets \>30,000 cells/mm# Exclusion Criteria: * Late persistent or recurrent aGVHD * Active uncontrolled infection * History of HIV infection * Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded. * Calculated CrCl \<30mL/min * AST and/or ALT \>5x ULN or direct bilirubin \>3x ULN * Cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias * Has received more than one allogeneic transplant prior to the occurrence of cGVHD
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-29
Estimated completion: 2027-12-31
Last updated: 2025-10-30
Interventions
Drug: BelumosudilDrug: Rituximab
Primary outcomes
  • Number of patients who achieve partial and complete responses after treatment (2 years)
Sponsor
Northside Hospital, Inc. · other
With: Sanofi
Contacts & investigators
ContactScott Solomon, MD · contact · ssolomon@bmtga.com · 404-255-1930
ContactCaitlin Guzowski, MBA, MHA · contact · caitlin.guzowski@northside.com · 404-851-8523
InvestigatorScott Solomon, MD · principal_investigator, BMTGA/Northside Hospital
All locations (1)
Northside HospitalRecruiting
Atlanta, Georgia, United States
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease · TrialPath