Belumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

This study is testing a new medicine called belumosudil for people with bronchiolitis obliterans syndrome (BOS), a lung disease that can happen after a stem cell transplant. Belumosudil is an immunotherapy that works by affecting the immune system and may also help reduce scarring in the lungs. You might receive belumosudil along with other standard BOS medicines like fluticasone, azithromycin, montelukast, and prednisone, or belumosudil alone. The study aims to see how many people respond well to treatment within 24 weeks. This study is for adults aged 18 and older who have been diagnosed with BOS after a stem cell transplant. The study is currently recruiting about 45 participants.

Study design: This is an open-label, single-arm, single-stage phase 2 study involving about 45 participants. Participants will be placed into one of two treatment groups.
What's involved: You will receive study treatment for 11 months (48 weeks). Procedures include screening, treatment visits, blood tests, lung function tests, bronchoscopy, and CT scans.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for an additional 12 months after completing study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting

PHASE2Ages 18+InterventionalTreatment

Dana-Farber Cancer Institute

~45 participants

Updated 2026-06-10 on ClinicalTrials.gov

What's tested:BelumosudilFluticasoneAzithromycinPrednisoneMontelukast

At a glance

Recruiting sites

4 of 6 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

24-week Overall Response Rate (ORR) [Cohort A]

Measured over up to 24 weeks.

+2 more outcomes measured

Conditions

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Lung Diseases

Chronic Graft Versus Host Disease

NCT05922761

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusettsstudy coordinator listed
Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusettsstudy coordinator listed
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Stanford University School of Medicine
Stanford, Californiastudy coordinator listed
Recruiting
University of Michigan
Ann Arbor, Michiganstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Corey Cutler, MD, MPH

[email protected]

617-632-5946

Email the study team

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Eligibility criteria

Inclusion

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 decline for the corrected values should still remain ≥ 10% over 2 years.

One of the two supporting features of BOS:

i - Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR

ii - Evidence of air trapping by PFTs: RV (Residual Volume) \> 120% of predicted or RV/TLC elevated outside the 90% confidence interval (RV/Total Lung Capacity).

Atypical Criteria for BOS:

FEV1 \<80% of predicted with ≥ 10% absolute decline over the last 2 years or since transplant. The remote comparator can be an evaluation of PFTs done within 2 years of the PFTs assessment being evaluated to determine eligibility or the PFT assessment done prior to transplant.

VC \< 80% of predicted.

FEV1/VC \> 0.7.

Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage) or active non-infectious lung disease (such as interstitial lung disease) that explain spirometric changes or chest CT findings.

Diagnosis of BOS-0p

Decline in FEV1 of 10% - 19% of predicted compared with pretransplant testing OR

Decline in predicted FEF25-75% (Forced Expiratory Flow between 25% and 75% of vital capacity) \> 25%

Age ≥18 years. Belumosudil is currently being tested in pediatric populations and the safety and efficacy in pediatric patients have not yet been established. A protocol amendment to include pediatric patients will be considered once safety in pediatric patients is established.

ECOG performance status ≤2 (Karnofsky ≥ 60%).

Participants must have adequate organ and marrow function as defined below:

WBC ≥ 3,000/μL

Absolute neutrophil count ≥ 1,500/ μL

Platelets ≥ 50,000/mcL

AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN

No evidence of relapsed malignancy at the time of enrollment. Formal re-staging is not required for trial entry.

All females of childbearing potential must have a negative serum or urine pregnancy test \< 7 days before study drug administration.

The ability to understand and willingness to sign a written consent document.

Exclusion

Participants who have received prior therapy specifically for BOS. Therapy for cGVHD in the absence of BOS is permissible.

Prior exposure to belumosudil.

Participants who are receiving any other investigational immunosuppressive agents for cGVHD.

Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persistent fever without signs or symptoms will not be interpreted as an active uncontrolled infection.

Known human immunodeficiency virus infection. Interactions between belumosudil and anti-retroviral agents have not been established.

Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.

What this trial measures

24-week Overall Response Rate (ORR) [Cohort A]up to 24 weeks.
24-week ORR defined as the proportion of participants achieving BOS complete response (CR) or partial response (PR) based on change in FEV1 measurement per criteria of the 2014 NIH Consensus Conference.
24-week Overall Response Rate (ORR) [Cohort B]up to 24 weeks.
24-week ORR defined as the proportion of participants achieving BOS complete response (CR) or partial response (PR) based on change in FEV1 measurement per criteria of the 2014 NIH Consensus Conference.
24-week Progression Rate [Cohort B]up to 24 weeks.
24-week progression rate is defined as the proportion of participants experiencing BOS progression based on change in FEV1 measurement per criteria of the 2014 NIH Consensus Conference.

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