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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060GVH4001 | Other Identifier | Janssen Korea, Ltd., Korea |
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After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Rate of Sustained Response | Sustained response rate will be assessed. | At least 5 months (up to 36 weeks) |
| Part B: Duration of Response | Duration of response will be assessed. |
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Inclusion Criteria:
Part A and Part B
Exclusion Criteria:
Part A and Part B
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Participants with steroid dependent or refractory chronic graft versus host disease (cGVHD) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | 14584 | South Korea | |||
| Pusan National University Hospital |
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| 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. | 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. | 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. | Up to 36 weeks |
| Busan |
| 49241 |
| South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Soonchunhyang University Seoul Hospital | Seoul | 04401 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Mary s Hospital | Seoul | 06591 | South Korea |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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