A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
- Conditions
- Chronic Graft vs Host Disease
- Registration Number
- NCT04852692
- Lead Sponsor
- Janssen Korea, Ltd., Korea
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Part A and Part B
- Must have a confirmed diagnosis of steroid dependent or refractory classic cGVHD defined at any time post-hematopoietic cell transplantation (HCT) as: a) refractory disease - progressive cGVHD manifestations requiring prednisolone at greater than or equal to (>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at >= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cGVHD manifestations requiring glucocorticoid >= prednisolone 0.25 mg/kg/day or >=0.5mg/kg every other day for at least 8 weeks Part A
- Treated at least 2 or more therapies for cGVHD (including glucocorticoids)
- Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy
- Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B
- Treated at least 3 lines therapies for cGVHD (including glucocorticoids)
- Participants who are treated with ibrutinib in their second-fourth line of therapy
Part A and Part B
- Known or suspected active acute GVHD
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A
- Treated with an investigational agent for their identified last-line of conventional salvage therapy
- Pregnant, breastfeeding during last-line of conventional salvage therapy Part B
- Pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A and Part B: Percentage of Participants with Overall Response Rate Week 24 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.
- Secondary Outcome Measures
Name Time Method Part A and Part B: Corticosteroid Requirement Changes Over Time Up to 24 weeks The change of the corticosteroid dose requirement during the treatment will be assessed.
Part B: Time to cGVHD Progression Up to 36 weeks 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.
Part B: Rate of Sustained Response At least 5 months (up to 36 weeks) Sustained response rate will be assessed.
Part B: Duration of Response Up to 5 months Duration of response will be assessed.
Part B: Change in Lee cGVHD Symptom Scale Up to 36 weeks Change in Lee cGVHD symptom scale will be assessed. It is a participant reported improvement in symptom burden.
Trial Locations
- Locations (8)
The Catholic University of Korea Seoul St Mary s Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon-Si, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of