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.
Time interval from transplant </= 5 years at the time of inclusion
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).
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