Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome

Phase

Condition

Respiratory Syncytial Virus (Rsv) Infection

Hematologic Neoplasms

Blood Cancer

Treatment

N/A

Clinical Study ID

NCT05413356

ZJU-HSCT-BOS

Ages 18-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female; 18-65 years old
Diagnosis of BOS after allo-HCT defined as the 2014 NIH criteria
Life expectancy > 6 months at the time of enrollment
At least 4 weeks since initiation of the most recent systemic therapy for cGVHD or BOS
The ability to understand and willingness to sign a written consent document

Exclusion

Exclusion Criteria:

Recurrent malignancy or disease progression requiring anticancer therapy
Currently receiving or have previously received ruxolitinib for chronic GVHD therapy
Known history of allergy to ruxolitinib or its excipients
Hepatic dysfunction: transaminases (ALT, AST) > 5X ULN and/or total bilirubin > 3X ULN
Hematologic dysfunction: absolute neutrophil count <1000/μL, platelet cout <30*10E9/L,and/or Hgb < 8 g/dL
Renal dysfunction: calculated creatinine clearance < 30 mL/min (Cockcroft-Gaultformula)
previously received second-line treatment or any drugs in clinical trials for cGVHD

Study Design

June 01, 2022

January 01, 2025

Study Description

The incidence of chronic graft versus host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) was 30%-70%, Which extremely limited the quality of life and the survival of patients after allo-HSCT. Lung is one of the target organs in cGVHD after 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.

Connect with a study center

The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang 310000
China
Active - Recruiting

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