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Immunosuppressive Agent

Belumosudil for Bronchiolitis Obliterans Syndrome

Q: Are there current opportunities to join this clinical experiment?

According to the clinicaltrials.gov page, this medical trial is not currently recruiting for participants as it was last modified on June 27th 2023. However, there are 1,884 other experiments that are actively enrolling patients at present.

Q: Has the FDA granted authorization for Cohort A: Belumosudil + Standard of Care Medications?

Our team evaluated the safety of Cohort A: Belumosudil + Standard of Care Medications to be a 2. This is owing to this being a Phase 2 trial, in which there are observations that suggest its security but no evidence confirming efficacy.

Q: What is the central focus of this investigation?

As reported by Sanofi, the primary outcome that will be measured over a period of 24 weeks is Cohort B's Overall Response Rate (ORR). Secondary objectives are 48-week Progression Rate [Cohort B], Grade 3-5 Treatment-Related Toxicity Rate and cGVHD Response. The latter two being defined as <a href="https://www.withpower.com/clinical-trials/all">all</a> grade 3-5 Adverse Events with attribution to treatment based on CTCAEv5 and chronic Graft Versus Host Disease response per criteria of the 2014 NIH Consensus Conference respectively.

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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

24-week Progression Rate [Cohort B]

Secondary outcome measures

48-week Progression Rate [Cohort B]

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

Chronic Graft Versus Host Disease (cGVHD) Response

+2 more

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

Azithromycin

2018

Completed Phase 4

~274950

Prednisone

2014

Completed Phase 4

~2370

Montelukast

2008

Completed Phase 4

~15460

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,079 Total Patients Enrolled

6 Trials studying Bronchiolitis Obliterans Syndrome

556 Patients Enrolled for Bronchiolitis Obliterans Syndrome

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,935 Total Patients Enrolled

4 Trials studying Bronchiolitis Obliterans Syndrome

427 Patients Enrolled for Bronchiolitis Obliterans Syndrome

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,932 Total Patients Enrolled

14 Trials studying Bronchiolitis Obliterans Syndrome

967 Patients Enrolled for Bronchiolitis Obliterans Syndrome

Media Library

Belumosudil (Immunosuppressive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05922761 — Phase 2

Bronchiolitis Obliterans Syndrome Research Study Groups: Cohort A: Belumosudil + Standard of Care Medications, Cohort B: Belumosudil

Bronchiolitis Obliterans Syndrome Clinical Trial 2023: Belumosudil Highlights & Side Effects. Trial Name: NCT05922761 — Phase 2

Belumosudil (Immunosuppressive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05922761 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities to join this clinical experiment?

"According to the clinicaltrials.gov page, this medical trial is not currently recruiting for participants as it was last modified on June 27th 2023. However, there are 1,884 other experiments that are actively enrolling patients at present."

Answered by AI

Has the FDA granted authorization for Cohort A: Belumosudil + Standard of Care Medications?

"Our team evaluated the safety of Cohort A: Belumosudil + Standard of Care Medications to be a 2. This is owing to this being a Phase 2 trial, in which there are observations that suggest its security but no evidence confirming efficacy."

Answered by AI

What is the central focus of this investigation?

"As reported by Sanofi, the primary outcome that will be measured over a period of 24 weeks is Cohort B's Overall Response Rate (ORR). Secondary objectives are 48-week Progression Rate [Cohort B], Grade 3-5 Treatment-Related Toxicity Rate and cGVHD Response. The latter two being defined as all grade 3-5 Adverse Events with attribution to treatment based on CTCAEv5 and chronic Graft Versus Host Disease response per criteria of the 2014 NIH Consensus Conference respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Corey S. Cutler, MD, MPH 2024. "BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05922761.

All > Graft Vs Host Disease