Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome

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.

Conditions

• Bronchiolitis Obliterans Syndrome
• Hematologic Malignancy

Interventions

DRUG

Ruxolitinib

Oral ruxolitinib twice daily

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhejiang Chinese Medical University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• The Affiliated People's Hospital of Ningbo University

  collaborator OTHER_GOV

• Jinhua Central Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Union hospital of Fujian Medical University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  lead OTHER

Principal Investigators

• Yi Luo, M.D. · First Affilaated Hospital of Medical School of Zhejiang University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2024-06-01

Completion

2025-01-01

Countries

• China

Study Locations