NCT03805477CompletedPhase 2
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
This study investigates the safety and tolerability of Nintedanib in patients with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic cell transplantation. All study patients with BOS will be treated with the study drug Nintedanib (300 mg/day) as an add-on therapy to their basic immunosuppressive treatment over a 12-months treatment period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 8 Jan 2019
- Start date
- 20 Mar 2019
- Primary completion date
- 29 Jul 2026
- Lead sponsor
- University Hospital, Basel, Switzerland
- NCT number
- NCT03805477
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 20 Mar 2019 to the primary completion date, 29 Jul 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any acute pulmonary infection with viruses, bacteria or fungi within four weeks before study inclusion
- Chronic oxygen therapy; non-invasive ventilation
Other illness
- Hematologic malignancy in hematologic relapse
- Symptomatic angina pectoris
- Recent abdominal surgery or untreated gastric ulcer
Lab values
- 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
- Therapeutic anticoagulation (primary or secondary prophylactic platelet anti-aggregation allowed)
Other
- Known intolerance to Nintedanib or any of its component
- Pregnancy or nursing
- 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
Who the study is looking for
- Time interval from transplant \</= 5 years at the time of inclusion
- BOS as defined per the National Institute of Health (NIH) criteria:
- FEV1/vital capacity \< 0.7 or the fifth percentile of predicted.
- FEV1 \< 75% of predicted with ≥ 10% decline over less than 2 years.
- 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).
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinic of Hematology, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Clinic of Respiratory Medicine, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| King Faisal Specialist Hospital & Research Centre Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.