Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05922761

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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