Status:
UNKNOWN
Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang Provincial People's Hospital
Conditions:
Bronchiolitis Obliterans Syndrome
Hematologic Malignancy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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-H...
Detailed 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 surviva...
Eligibility Criteria
Inclusion
- 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
- 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-Gault formula)
- previously received second-line treatment or any drugs in clinical trials for cGVHD
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05413356
Start Date
June 1 2022
End Date
January 1 2025
Last Update
October 19 2022
Active Locations (1)
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1
The first Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000