BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Part of paid clinical trials in Stanford, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05922761
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belumosudil — DRUG
    Kinase inhibitor, tablet taken orally
  • Fluticasone — DRUG
    Via inhalation by metered-dose inhaler.
  • Azithromycin — DRUG
    Semi-synthetic macrolide antibiotic, taken orally
  • Prednisone — DRUG
    Corticosteroid, taken orally
  • Montelukast — DRUG
    Leukotriene Receptor Antagonist, taken orally

Study Details

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)

Key Dates

Start date
May 31, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Belumosudil + Standard of Care Medications
    30 participants with bronchiolitis obliterans syndrome (BOS) will complete study procedures as follows: * Drug diary * CT scans at Cycles 3 and 7 and at End of Treatment. * Cycle 1 * Day 1 - 28 of 28-day cycle: Predetermined dose of Belumosudil 1x daily. * Predetermined doses of Fluticasone, Montelukast, and Prednisone 1x daily. * Predetermined dose of azithromycin 3 days per treatment week. * Cycle 2 - 3 * Day 1 - 28 of 28-day cycle: Predetermined dose of Belumosudil 1x daily. * Predetermined doses of Fluticasone Montelukast 1x daily. Predetermined doses of Prednisone 1x daily at treating physician's discretion. * Predetermined dose of azithromycin 3 days per treatment week. * Cycle 4 - 12 * Day 1 - 28 of 28-day cycle: Predetermined dose of Belumosudil 1x daily. * Predetermined doses of Fluticasone and Montelukast 1x daily. * Predetermined dose of azithromycin 3 days per treatment week.
  • Experimental: Cohort B: Belumosudil
    15 participants with signs concerning developing BOS will complete study procedure as follows: * Drug diary * CT scans at Cycles 3 and 7 and at End of Treatment. * Cycle 1 - 12 - Day 1 - 28 of 28-day cycle: Predetermined dose of Belumosudil 1x daily.

Primary Outcome Measure

24-week Overall Response Rate (ORR) [Cohort A] [ Time Frame: up to 24 weeks. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305
Joe L Hsu, MD
[email protected]
Joe L Hsu, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02215
Corey Cutler, MD, MPH
[email protected]
617-632-5946
Brigham and Women's HospitalBostonMassachusetts02215
Corey Cutler, MD, MPH
[email protected]
617-632-5946
Dana-Farber Cancer InstituteBostonMassachusetts02115
Corey Cutler, MD, MPH
[email protected]
617-632-3470
Corey Cutler, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Gregory A Yanik, MD, BS
[email protected]
8008651125
Gregory A Yanik, MD, BS (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Guang-Shing Cheng
[email protected]
Guang-Shing Cheng, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CABoston Children's Hospital· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MIFred Hutchinson Cancer Center· Seattle, WA

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