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
Dana-Farber Cancer Institute
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)
Description
This is an open-label, single-arm, single-stage phase 2 study to evaluate the activity of Belumosudil in subjects with new onset of bronchiolitis obliterans syndrome (BOS) (Cohort A) and for subjects with incipient BOS (Cohort B) following allogeneic hematopoietic cell transplantation (HCT). Belumosudil is a novel immunosuppressive agent that has both immunosuppressive activity as well as antifibrotic (slowing down the rate of fibrosis or scarring in the lungs) properties. Participants will be placed into one of two treatment groups: Group A Belumosudil + standard of care medications for BOS…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Cohort A: * Diagnosis of BOS after HCT using pulmonary function testing, per the NIH diagnostic criteria17 OR the Atypical BOS criteria33 3.1.2.1 NIH Diagnostic Criteria for BOS. All of the following must be met: * FEV1/VC \< 0.7 or \<5th percentile of predicted (FEV1 = Forced Expiratory Volume in 1 second; VC = Vital Capacity (either FVC, Forced Vital Capacity, or SVC, Slow Vital Capacity, whichever is greater) * FEV1 \<75% of predicted with ≥ 10% absolute decline over less than 2 years. FEV1 should not correct to \>75% of predicted with albuterol, and the absolute de…
Interventions
- DrugBelumosudil
Kinase inhibitor, tablet taken orally
- DrugFluticasone
Via inhalation by metered-dose inhaler.
- DrugAzithromycin
Semi-synthetic macrolide antibiotic, taken orally
- DrugPrednisone
Corticosteroid, taken orally
- DrugMontelukast
Leukotriene Receptor Antagonist, taken orally
Locations (5)
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Boston Children's HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Fred Hutchinson Cancer CenterSeattle, Washington