Phase 2 Study of Belumosudil and Rituximab as First Treatment for Extensive Chronic Graft-Versus-Host Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the drugs belumosudil and rituximab as a first treatment for people with extensive chronic graft-versus-host disease cGVHD. This Phase 2, open-label study focuses on patients experiencing their first episode of cGVHD that requires systemic immunosuppression. The study is sponsored by Northside Hospital, Inc. and aims to understand how well these treatments work and how safe they are over time. Participants will receive belumosudil taken orally at 200 mg once daily for 24 cycles of 28 days each. Alongside this, rituximab will be given through intravenous infusion at 375 mgm2 weekly for the first four weeks, then once every three months for four additional doses. This combined treatment regimen is designed to be the primary therapy for their cGVHD. During the study, participants will be closely monitored for treatment response, including the number achieving partial or complete responses over two years. Researchers will also track how long patients remain on corticosteroid therapy and record any treatment-related side effects using standardized criteria. The study involves regular assessments of health status and treatment effects for a total duration of two years, ensuring comprehensive safety and efficacy evaluation.

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