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Immunosuppressive Agent

Belumosudil for Bronchiolitis Obliterans Syndrome

Phase 2

Recruiting

Led By Corey Cutler, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

FEV1 <80% of predicted with ≥ 10% absolute decline over the last 2 years or since transplant

ECOG performance status ≤2

Must not have

Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation

Prior exposure to belumosudil

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a novel immunosuppressive agent to treat newly diagnosed or early stage bronchiolitis obliterans syndrome in HSCT recipients.

Who is the study for?

This trial is for adults over 18 with early stage bronchiolitis obliterans syndrome (BOS) after a stem cell transplant. They must have specific lung function test results, no active infections or recent cancers, and not be on other investigational drugs for chronic graft-versus-host disease.

What is being tested?

The BEBOP study tests the effectiveness of belumosudil, an immunotherapy drug, in combination with fluticasone (a steroid), azithromycin (an antibiotic), montelukast (for asthma), and prednisone (another steroid) to treat BOS in stem cell transplant recipients.

What are the potential side effects?

Potential side effects may include immune system suppression leading to increased infection risk, possible liver enzyme elevation due to medications involved, and typical side effects from steroids such as mood swings, weight gain, or increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung function has significantly declined in the last 2 years or since my transplant.

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I can take care of myself but might not be able to do heavy physical work.

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My lung function has significantly declined in less than 2 years.

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I do not have any current infections in my lungs or airways.

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I have been diagnosed with BOS after a stem cell transplant.

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I am 18 years old or older.

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My cancer has not come back at the time of signing up.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active hepatitis B or C infection needing treatment.

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I have previously been treated with belumosudil.

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I am HIV positive.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I have received treatment for BOS before.

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I currently have an infection that isn't under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

24-week Progression Rate [Cohort B]

Secondary study objectives

48-week Progression Rate [Cohort B]

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

Chronic Graft Versus Host Disease (cGVHD) Response

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: BelumosudilExperimental Treatment1 Intervention

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.

Group II: Cohort A: Belumosudil + Standard of Care MedicationsExperimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil

2018

Completed Phase 2

~320

Fluticasone

2008

Completed Phase 4

~2370