A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Part A: Retrospective Phase Retrospective collection of data for eligible participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) who initiated salvage treatments from initiation point (administration starting point of the salvage treatment) of the identified last-line of conventional salvage therapy for cGVHD treatment as their second-forth line therapy and will be collected for up to 24 weeks from the initiation point. |
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| Part B: Prospective Phase Prospectively enroll participants with steroid dependent/refractory cGVHD that are decided to be treated with ibrutinib in second-fourth line therapy for the treatment of cGVHD. Participants will continue to receive corticosteroids as a standard of care. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 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: 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Part A and Part B
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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
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Treated at least 2 or more therapies for cGVHD (including glucocorticoids)
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Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy
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Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B
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Treated at least 3 lines therapies for cGVHD (including glucocorticoids)
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Participants who are treated with ibrutinib in their second-fourth line of therapy
Exclusion Criteria:
Part A and Part B
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Known or suspected active acute GVHD
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Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A
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Treated with an investigational agent for their identified last-line of conventional salvage therapy
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Pregnant, breastfeeding during last-line of conventional salvage therapy Part B
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Soonchunhyang University Bucheon Hospital | Bucheon-Si | Korea, Republic of | 14584 | |
| 2 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 3 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 4 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 35015 | |
| 5 | Chonnam National University Hwasun Hospital | Hwasun | Korea, Republic of | 58128 | |
| 6 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 7 | Severance Hospital | Seoul | Korea, Republic of | 03722 | |
| 8 | Soonchunhyang University Seoul Hospital | Seoul | Korea, Republic of | 04401 | |
| 9 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 10 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 06591 |
Sponsors and Collaborators
- Janssen Korea, Ltd., Korea
Investigators
- Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108945
- 54179060GVH4001