Actively Recruiting
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
Led by Dana-Farber Cancer Institute · Updated on 2026-02-11
45
Participants Needed
5
Research Sites
187 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
The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS). The name of the study drugs involved in this study are: * Belumosudil (an immunotherapy) * Fluticasone (an intranasal corticosteroid) * Azithromycin (an antibiotic) * Montelukast (a leukotriene receptor antagonist) * Prednisone (a corticosteroid)
CONDITIONS
Official Title
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of bronchiolitis obliterans syndrome (BOS) after hematopoietic cell transplantation (HCT) confirmed by pulmonary function tests or atypical BOS criteria
- Decline in lung function measures consistent with BOS or incipient BOS
- Age 18 years or older
- ECOG performance status of 0 to 2 (Karnofsky score 60% or higher)
- Adequate organ and marrow function: WBC ≥ 3,000/µL, absolute neutrophil count ≥ 1,500/µL, platelets ≥ 50,000/mcL, AST/ALT ≤ 5 times institutional upper limit
- No evidence of relapsed malignancy
- Negative pregnancy test for females of childbearing potential within 7 days before study drug
- Ability to understand and willing to sign consent
You will not qualify if you...
- Prior therapy specifically for BOS
- Previous exposure to belumosudil
- Receiving other investigational immunosuppressive agents for chronic graft versus host disease (cGVHD)
- Active uncontrolled infection defined by clinical instability or worsening infection symptoms
- Known HIV infection
- Active hepatitis B or hepatitis C infection requiring treatment or at risk of hepatitis B reactivation
AI-Screening
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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
CONTACT
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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