Actively Recruiting
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation
Led by University Hospital, Basel, Switzerland · Updated on 2025-12-15
20
Participants Needed
3
Research Sites
401 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Time interval from transplant less than or equal to 5 years at the time of inclusion
- Diagnosis of bronchiolitis obliterans syndrome (BOS) as defined by NIH criteria:
- FEV1/vital capacity less than 0.7 or below the fifth percentile of predicted
- FEV1 less than 75% of predicted with at least 10% decline over less than 2 years
- No infection in the respiratory tract confirmed by clinical investigations
- One supporting feature of BOS such as evidence of air trapping or small airway changes by CT or pulmonary function tests, or prior/current diagnosis of chronic graft-versus-host disease or biopsy-proven bronchiolitis obliterans
- Diagnosis of BOS within 6 months before enrollment or prior diagnosis with a decline in FEV1 by at least 10% within the past 12 months
You will not qualify if you...
- Known intolerance to Nintedanib or any of its components
- Pregnancy or nursing
- Serum ALT greater than 5 times upper limit of normal unless explained by liver graft-versus-host disease
- Total bilirubin greater than 3 times upper limit of normal unless explained by liver graft-versus-host disease
- Any acute pulmonary infection within 4 weeks before study inclusion
- Use of chronic oxygen therapy or non-invasive ventilation
- Inability to give informed consent or perform repeated pulmonary function tests
- Life expectancy less than 1 year at enrollment
- Hematologic malignancy in relapse
- Symptomatic angina pectoris
- Therapeutic anticoagulation (except platelet anti-aggregation)
- Recent abdominal surgery or untreated gastric ulcer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11471
Actively Recruiting
2
Clinic of Hematology, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
3
Clinic of Respiratory Medicine, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
K
Katrin Hostettler Haack, PD Dr. med
CONTACT
S
Sandra Kunze
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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