RecruitingPhase 2NCT03805477

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

20 participants

Start Date

Mar 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called nintedanib — already approved for lung scarring diseases — in people who have developed a serious lung complication called Bronchiolitis Obliterans Syndrome (BOS) after a bone marrow or stem cell transplant. BOS causes the small airways in the lungs to become inflamed and scarred, making it progressively harder to breathe. Researchers want to find out whether nintedanib can slow or stop this decline in lung function. You may be eligible if: - You are 18 or older and received a stem cell transplant within the past 5 years - You have been diagnosed with BOS according to NIH criteria (low FEV1, absence of respiratory infection, and supporting imaging or lung function evidence) - You were diagnosed with BOS within the past 6 months, or your lung function has declined by 10% or more in the past year You may NOT be eligible if: - You have known intolerance to nintedanib - You are pregnant or breastfeeding - You have severely abnormal liver tests (unless caused by GvHD) - You have had a lung infection in the past 4 weeks - You require chronic oxygen therapy or ventilator support - Your blood cancer has relapsed, or you have less than 1 year life expectancy - You are on therapeutic anticoagulation (blood thinners) Talk to your doctor about whether your current medications, liver function, and transplant history make you a good candidate for this trial.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNintedanib

Nintedanib 150 mg Kps bid (oral); in order to manage adverse events, the dose of Nintedanib may be reduced from 150 mg twice daily to 100 mg twice daily


Locations(3)

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Clinic of Hematology, University Hospital Basel

Basel, Switzerland

Clinic of Respiratory Medicine, University Hospital Basel

Basel, Switzerland

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NCT03805477