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RECRUITING
NCT05922761
PHASE2

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Sponsor: Dana-Farber Cancer Institute

View on ClinicalTrials.gov

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)

Official title: An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-05-31

Completion Date

2027-12-31

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

Belumosudil

Kinase inhibitor, tablet taken orally

DRUG

Fluticasone

Via inhalation by metered-dose inhaler.

DRUG

Azithromycin

Semi-synthetic macrolide antibiotic, taken orally

DRUG

Prednisone

Corticosteroid, taken orally

DRUG

Montelukast

Leukotriene Receptor Antagonist, taken orally

Locations (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States