BridgeMD
Prevention study for Bronchiolitis Obliterans Syndrome
Official title BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
ClinicalTrials.gov ID: NCT05922761
What this study is testing
What is Belumosudil?
Belumosudil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bronchiolitis obliterans syndrome.
Also referred to as Rezurock, KD025, 2-{3-[4-(1H-indazol-5-ylamino)-2-quinazolinyl]phenoxy}-N-(propan-2-yl) acetamide, C26H24N6O2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- FEV1/VC \< 0.7 or \<5th percentile of predicted (FEV1 = Forced Expiratory Volume in 1 second; VC = Vital Capacity (either FVC, Forced Vital Capacity...
- FEV1 \ 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...
You likely can't join if
- for Cohorts A and B:
- 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...
- Known human immunodeficiency virus infection. Interactions between belumosudil and anti-retroviral agents have not been established.
See the full eligibility 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 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...
- 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...
- 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...
- 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% for Cohorts A and B:
- Age ≥18 years. Belumosudil is currently being tested in pediatric populations and the safety and how well it works in pediatric patients have not yet been established. A protocol amendment to include pediatric patients...
- 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.
- for Cohorts A and B:
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.