Using Nintedanib to treat bronchiolitis obliterans syndrome after stem cell transplantation
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial
This study is testing if adding a medication called Nintedanib can help people with bronchiolitis obliterans syndrome after a stem cell transplant feel better and improve their lung health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 3 sites (Riyadh and 2 other locations) |
| Trial ID | NCT03805477 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of Nintedanib in patients diagnosed with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic stem cell transplantation. Participants will receive Nintedanib as an add-on therapy to their existing immunosuppressive treatment for a duration of 12 months. The study aims to address the poor prognosis associated with BOS, which can occur as a complication of chronic graft-versus-host disease. By targeting the underlying fibrotic processes in the lungs, Nintedanib may offer a new therapeutic option for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been diagnosed with bronchiolitis obliterans syndrome within 5 years of undergoing allogeneic hematopoietic stem cell transplantation.
Not a fit: Patients who have not been diagnosed with bronchiolitis obliterans syndrome or those with active respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve lung function and overall survival for patients suffering from bronchiolitis obliterans syndrome.
How similar studies have performed: While the use of Nintedanib in this specific context is novel, similar anti-fibrotic approaches have shown promise in treating other fibrotic lung diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Time interval from transplant \</= 5 years at the time of inclusion * BOS as defined per the National Institute of Health (NIH) criteria: 1. FEV1/vital capacity \< 0.7 or the fifth percentile of predicted. 2. FEV1 \< 75% of predicted with ≥ 10% decline over less than 2 years. 3. Absence of infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs, computed tomographic (CT) scans, or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, and broncho-alveolar lavage). 4. One of the 2 supporting features of BOS: 1. Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT, or 2. Evidence of air trapping by PFTs: residual volume \> 120% of predicted or residual volume/total lung capacity elevated outside the 90% confidence interval and prior or current diagnosis of cGvHD per NIH criteria or histologically proven BO * Diagnosis of BOS within 6 months before enrollment or prior diagnosis of BOS with an absolute decline of the percentage of predicted forced expiratory volume in 1 second (FEV1) by \>/= 10% within the past 12 months before inclusion Exclusion Criteria * Known intolerance to Nintedanib or any of its component * Pregnancy or nursing * Serum ALT \> 5 x upper limit of normal (ULN) unless explained entirely by liver GvHD or total bilirubin \> 3x ULN unless explained entirely by liver GvHD * Any acute pulmonary infection with viruses, bacteria or fungi within four weeks before study inclusion * Chronic oxygen therapy; non-invasive ventilation * Inability to give informed consent or to perform repeated pulmonary function tests (PFT) * Life expectancy \< 1 year at the time of enrolment as suggested by the treating physician * Hematologic malignancy in hematologic relapse * Symptomatic angina pectoris * Therapeutic anticoagulation (primary or secondary prophylactic platelet anti-aggregation allowed) * Recent abdominal surgery or untreated gastric ulcer
Where this trial is running
Riyadh and 2 other locations
- King Faisal Specialist Hospital & Research Centre — Riyadh, Saudi Arabia (Recruiting)
- Clinic of Hematology, University Hospital Basel — Basel, Switzerland (Recruiting)
- Clinic of Respiratory Medicine, University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Katrin Hostettler Haack, PD Dr. med — Clinic of Respiratory Medicine, University Hospital Basel
- Study coordinator: Katrin Hostettler Haack, PD Dr. med
- Email: Katrin.Hostettler@usb.ch
- Phone: +41 61 328 69 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.