Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Lung is one of the target organs in chronic graft versus host disease (cGVHD) after
allogeneic hematopoietic stem cell transplantation (allo-HSCT). Bronchiolitis obliterans
syndrome (BOS) after allo-HSCT was a clinical syndrome characterized by persistent airflow
restriction which is the result of lung cGVHD. BOS is one of the main causes of late
mortality after allo-HSCT, severely restricting the daily activities and respiratory function
of patients. It limits the quality of life and increased the non-relapse mortality (NRM)
after allo-HSCT. Currently, the first-line treatment for BOS is FAM ( oral fluticasone,
azithromycin and montelukast). However, more than 50% of patients develop as steroids
resistant (SR)-BOS, and SR-BOS has a poor prognosis and irreversible impaired lung function.
Ruxolitinib is an effective drug in the treatment of SR-cGVHD. This is a phase Ⅱ prospective
clinical study to explore the efficacy and safety of ruxolitinib as a first-line treatment
for newly diagnosed BOS after allo-HSCT.
Phase:
Phase 2
Details
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborators:
First Affiliated Hospital of Wenzhou Medical University Jinhua Central Hospital Ningbo First People's Hospital Second Affiliated Hospital, School of Medicine, Zhejiang University Sir Run Run Shaw Hospital Taizhou Hospital The affiliated people's hospital of Ningbo University The First Affiliated Hospital of Zhejiang Chinese Medical University Union hospital of Fujian Medical University Xiangya Hospital of Central South University Zhejiang Provincial People's Hospital