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NCT06046248PHASE2Recruiting

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

Northside Hospital, Inc.

Start Date

1/29/2024

Completion Date

12/31/2027

Summary

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Belumosudil

DRUG

Rituximab

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Conditions

Chronic Graft Versus Host Disease

Locations

Northside Hospital

Atlanta, Georgia 30342

United States