RECRUITING

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-05-31
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05922761

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Corey Cutler, MD, MPH
CONTACT
617-632-5946
CSCUTLER@PARTNERS.ORG

Principal Investigator

Corey Cutler, MD, MPH
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Boston Children's Hospital
Boston, Massachusetts, 02215
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Corey Cutler, MD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-31
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-05-31
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Bronchiolitis Obliterans Syndrome
  • Bronchiolitis Obliterans
  • Lung Disease
  • Allogeneic hematopoietic stem cell transplant
  • HSCT
  • Chronic Graft Versus Host Disease

Additional Relevant MeSH Terms

  • Bronchiolitis Obliterans Syndrome
  • Bronchiolitis Obliterans
  • Lung Diseases
  • Chronic Graft Versus Host Disease