BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
NCT05922761 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-02-11
Summary
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
- Bronchiolitis Obliterans Syndrome
- Bronchiolitis Obliterans
- Lung Diseases
- Chronic Graft Versus Host Disease
Interventions
- DRUG
-
Belumosudil
Kinase inhibitor, tablet taken orally
- DRUG
-
Fluticasone
Via inhalation by metered-dose inhaler.
- DRUG
-
Semi-synthetic macrolide antibiotic, taken orally
- DRUG
-
Corticosteroid, taken orally
- DRUG
-
Montelukast
Leukotriene Receptor Antagonist, taken orally
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH - lead OTHER
Principal Investigators
-
Corey Cutler, MD, MPH · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-31
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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