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Bronchiolitis Obliterans SyndromePhase 2NCT05922761

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

A Phase 2 study testing Belumosudil, Fluticasone and Azithromycin in people with Bronchiolitis Obliterans Syndrome and Bronchiolitis Obliterans, run by Dana-Farber Cancer Institute at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Belumosudil, Fluticasone and Azithromycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
6 sitesUnited States
Study dates
31 May 2024to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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).
  • 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
Show all 25Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Corey Cutler, MD, MPH contact

617-632-5946

CSCUTLER@PARTNERS.ORG

6 sites in 1 country

United States6 sites, 6 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Gregory A Yanik, MD, BS, 8008651125, gyanik@med.umich.edu

    Gregory A Yanik, MD, BS

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

    Corey Cutler, MD, MPH, 617-632-3470, cscutler@partners.org

    Corey Cutler, MD, MPH

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02215

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

    Not yet recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215

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

    Not yet recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Guang-Shing Cheng, gcheng2@fredhutch.org

    Guang-Shing Cheng, MD

    Recruiting

  • Stanford University School of Medicine

    Stanford, California, 94305

    Joe L Hsu, MD, joehsu@stanford.edu

    Joe L Hsu, MD

    Recruiting

Other trials in United States

About this study

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

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)
Read the detailed 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 versus Group B Belumosudil only.

The U.S. Food and Drug Administration (FDA) has not approved belumosudil for the initial or preventative therapy of BOS, but it has been approved for the treatment of Chronic Graft Versus Host Disease (cGVHD).

The other study drugs, Fluticasone, Azithromycin, Montelukast, and Prednisone are FDA approved as standard of care drugs for BOS.

Study procedures include screening for eligibility, treatment visits, blood tests, pulmonary function tests, bronchoscopy wit bronchoalveolar lavage, and Computed Tomography (CT) Scans.

Participants will receive study treatment for 11 months (48 weeks) and will be followed for an additional 12 months after completion of study treatment.

It is expected that about 45 people (30 in Group A and 15 in Group B) will take part in this research study.

The National Heart, Lung, and Blood Institute (NHLBI) is supporting this research study by providing funding.

Sanofi is supporting this research study by providing study drug, Belumosudil.

Being tested
Belumosudil, Fluticasone, Azithromycin, Prednisone, Montelukast
Keywords
Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans, Lung Disease, Allogeneic hematopoietic stem cell transplant, HSCT, Chronic Graft Versus Host Disease
Medical subject headings
Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelumosudilDrug

    Also called Rezurock, KD025, 2-{3-[4-(1H-indazol-5-ylamino)-2-quinazolinyl]phenoxy}-N-(propan-2-yl) acetamide, C26H24N6O2

    Kinase inhibitor, tablet taken orally

  • FluticasoneDrug

    Also called Fluticasone Propionate

    Via inhalation by metered-dose inhaler.

  • AzithromycinDrug

    Also called Zithromax

    Semi-synthetic macrolide antibiotic, taken orally

  • PrednisoneDrug

    Corticosteroid, taken orally

  • MontelukastDrug

    Also called Singulair

    Leukotriene Receptor Antagonist, taken orally

Study groups in NCT05922761
Study groupRoleWhat they receive
Cohort A: Belumosudil + Standard of Care MedicationsExperimental30 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.
Receives: Drug: Belumosudil; Drug: Fluticasone; Drug: Azithromycin; Drug: Prednisone; Drug: Montelukast
Cohort B: BelumosudilExperimental15 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.
Receives: Drug: Belumosudil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-week Overall Response Rate (ORR) [Cohort A]

    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.

    Measured: up to 24 weeks.

  2. 24-week Overall Response Rate (ORR) [Cohort B]

    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.

    Measured: up to 24 weeks.

  3. 24-week Progression Rate [Cohort B]

    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.

    Measured: up to 24 weeks.

Secondary outcomes (5)

  1. 48-weeks Overall Response Rate (ORR) [Cohort A]

    48-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.

    Measured: Evaluated every 8 weeks, up to 48 weeks.

  2. 48-week Progression Rate [Cohort B]

    48-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.

    Measured: Evaluated every 8 weeks, up to 48 weeks.

  3. Grade 3-5 Treatment-Related Toxicity Rate

    All grade 3-5 AEs with attribution of probably, possibly or definitely-related to treatment based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.

    Measured: Evaluated on cycle 1 day 15, cycle 2, 3, 5, 7, 9, 11 (cycle duration=4 weeks) and end of treatment. Observed on treatment up to 12 cycles (48 weeks).

  4. Chronic Graft Versus Host Disease (cGVHD) Response

    cGVHD response will be evaluated using non-pulmonary measurements per criteria of the 2014 NIH Consensus Conference.

    Measured: Evaluated every 8 weeks, up to 48 weeks.

  5. Lee Symptom Scale (LSS) Quality of Life (QOL) Score

    Mean and standard deviation Lee Symptom Scale Quality of Life score estimated at each assessment timepoint. The LSS QOL scale is a 30-item measure with answers ranging from 0 "Not at All" to 4 "Extremely." Higher scores indicate greater symptom burden.

    Measured: Evaluated on cycle 1 day 15, cycle 2, 3, 5, 7, 9, 11 (cycle duration=4 weeks) and end of treatment. Observed on treatment up to 12 cycles (48 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start31 May 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05922761
Sponsor's protocol ID
23-043
Status last verified
Feb 2026
First submitted
3 Jun 2023
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belumosudil, Fluticasone and Azithromycin in people with Bronchiolitis Obliterans Syndrome and Bronchiolitis Obliterans, run by Dana-Farber Cancer Institute at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Corey Cutler, MD, MPH (617-632-5946, CSCUTLER@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-week Overall Response Rate (ORR) [Cohort A] (time frame: up to 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05922761.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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