Study of Belumosudil With or Without Standard Care for New and Early Bronchiolitis Obliterans Syndrome After Stem Cell Transplant

What this Trial Is About

Researchers are studying the effects of belumosudil, a new immunosuppressive drug, in people who have received allogeneic hematopoietic stem cell transplants and are newly diagnosed or developing early-stage bronchiolitis obliterans syndrome BOS. This phase 2 open-label study aims to evaluate belumosudils ability to treat BOS, a lung condition involving scarring and inflammation. The study is supported by the National Heart, Lung, and Blood Institute and Sanofi, with belumosudil approved for chronic graft-versus-host disease but not yet for BOS. Participants are assigned to one of two groups Group A receives belumosudil with standard BOS medications fluticasone, azithromycin, montelukast, and prednisone, while Group B receives belumosudil alone. Treatment involves daily oral doses of belumosudil and other drugs given in 28-day cycles for 11 months 48 weeks. Participants will have CT scans at multiple points during treatment and keep drug diaries. After treatment ends, participants are followed for an additional 12 months. During the study, participants undergo screening, blood tests, lung function tests, bronchoscopy with lavage, and CT scans. Researchers will monitor lung response, disease progression, symptom scores, and treatment-related side effects for up to 48 weeks. Quality of life and chronic graft-versus-host disease symptoms are also assessed regularly. The total participation time includes treatment and follow-up periods, lasting about 23 months in total.

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)