Actively Recruiting
An Open-Label Phase 2 Study Evaluating Belumosudil Alone or With Standard Care in New Onset and Early Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation
Led by Dana-Farber Cancer Institute · Updated on 2026-02-11
45
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of belumosudil, a new immunosuppressive drug, in people who have received allogeneic hematopoietic stem cell transplants and are newly diagnosed or showing early signs of bronchiolitis obliterans syndrome (BOS). This condition affects the lungs and can happen after stem cell transplants. The study is a phase 2, open-label, single-arm trial supported by the National Heart, Lung, and Blood Institute and Sanofi, focusing on measuring response rates and progression of BOS with belumosudil treatment. Participants will be assigned to one of two groups: Group A will receive belumosudil along with standard care medications for BOS, including fluticasone, azithromycin, montelukast, and prednisone, while Group B will receive belumosudil alone. Treatments are given daily in 28-day cycles over 11 months (48 weeks). Group A participants will follow a schedule of doses for each medication with azithromycin taken three days per week, while Group B participants will take only belumosudil daily. CT scans and drug diaries are part of the treatment monitoring. During the study, participants will undergo screening, treatment visits, blood tests, lung function tests, bronchoscopies with lavage, and CT scans at specified cycles. Researchers will track how well the lungs respond to treatment and monitor side effects, quality of life, and symptoms related to chronic graft versus host disease. After completing 48 weeks of treatment, participants will be followed for an additional 12 months to observe long-term effects and disease progression.
CONDITIONS
Brief Title
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of bronchiolitis obliterans syndrome (BOS) after hematopoietic cell transplantation (HCT) based on NIH or atypical criteria, including specific lung function test results
- Diagnosis of incipient BOS characterized by early declines in lung function tests
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Adequate organ and marrow function, including specified blood counts and liver enzyme limits
- No evidence of relapsed malignancy at enrollment
- Negative pregnancy test for females of childbearing potential within 7 days before treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment specifically for BOS
- Previous exposure to belumosudil
- Use of other investigational immunosuppressive agents for chronic graft versus host disease (cGVHD)
- Presence of active uncontrolled infection or sepsis
- Known HIV infection
- Active hepatitis B or C infection requiring treatment or risk for hepatitis B reactivation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 11 months (48 weeks)
Participants receive Belumosudil either alone or with standard of care medications for bronchiolitis obliterans syndrome. Treatment includes daily oral study drugs taken in cycles, along with periodic CT scans and various assessments.
Treatment visits every 28 days during 12 cycles; CT scans at Cycles 3, 7, and end of treatment; additional assessments on specific cycle days
Duration - 12 months
Participants are followed for an additional 12 months after completing study treatment to monitor long-term outcomes.
Periodic follow-up visits during the 12-month post-treatment period
Trial Site Locations
Total: 5 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Corey Cutler, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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