The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health \[NIH\] response defined complete response \[CR\] and partial response \[PR\]) at Week 24.
Study Type
OBSERVATIONAL
Enrollment
15
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Seoul National University Hospital
Seoul, South Korea
Part A and Part B: Percentage of Participants with Overall Response Rate
Overall response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) according to modified National Institutes of Health (NIH) response.
Time frame: Week 24
Part B: Rate of Sustained Response
Sustained response rate will be assessed.
Time frame: At least 5 months (up to 36 weeks)
Part B: Duration of Response
Duration of response will be assessed.
Time frame: Up to 5 months
Part A and Part B: Corticosteroid Requirement Changes Over Time
The change of the corticosteroid dose requirement during the treatment will be assessed.
Time frame: Up to 24 weeks
Part B: Time to cGVHD Progression
Time to chronic graft versus host disease (cGVHD) progression is defined as the time from the first dose of the ibrutinib to modified NIH response defined progression.
Time frame: Up to 36 weeks
Part B: Change in Lee cGVHD Symptom Scale
Change in Lee cGVHD symptom scale will be assessed. It is a participant reported improvement in symptom burden.
Time frame: Up to 36 weeks
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Severance Hospital
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Soonchunhyang University Seoul Hospital
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