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Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
RecruitingPhase 2
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
Who can join
Ages 18 and older · All sexes
Full 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
About the 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.
What is being tested
- Belumosudil (drug)
- Rituximab (drug)
Sponsor: Northside Hospital, Inc. · Participants: 25 · Started: Jan 29, 2024
Contact the study team
- Scott Solomon, MD · Phone: 404-255-1930
- Caitlin Guzowski, MBA, MHA · Phone: 404-851-8523
Official record on ClinicalTrials.gov — NCT06046248
Locations in the U.S.
| Georgia | Northside Hospital, Atlanta |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.