Status:
TERMINATED
A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Chronic Graft vs Host Disease
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04852692
Start Date
June 21 2021
End Date
August 6 2021
Last Update
May 23 2025
Active Locations (8)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea, 14584
2
Pusan National University Hospital
Busan, South Korea, 49241
3
Kyungpook National University Hospital
Daegu, South Korea, 41944
4
Seoul National University Hospital
Seoul, South Korea, 03080