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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060CLL3005 | Other Identifier | Janssen-Cilag Farmaceutica Ltda. |
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The purpose of this study is to provide early access to Ibrutinib treatment for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and collect additional safety data while the medication is not commercially available.
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) early access program (EAP) study. The study will be conducted in 2 phases: a Screening Phase (approximately 30 days prior to administration of first dose) and a Program Drug Phase (Day 1 up to 30 Days after last dose of study drug). Enrolled participants will receive 420 milligram (mg) oral ibrutinib once daily on a 28-day cycle until disease progression, occurrence of unacceptable toxicity, no longer achieving clinical benefit, or the end of program. Treatment will be continuous (without interruption) and self-administered. Disease evaluations will be conducted according to local standard of care as clinically indicated. Participant's safety will be monitored throughout the study. All enrolled and on-going participants in the program will continue to receive ibrutinib by the EAP until marketing approval or 6 months after this date.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI-32765 (Ibrutinib) | Drug | Participants will receive PCI-32765 (ibrutinib) 420 mg (three 140-mg capsules) oral once daily continuously on a 28-day cycle. |
Inclusion Criteria:
Has Eastern Cooperative Oncology Group (ECOG) performance status of less than (<) 2
Has a diagnosis of Chronic Lymphocytic Leukemia (CLL) that meets published diagnostic criteria (Hallek 2008):
Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria
Must have received at least one prior therapy for CLL and not be appropriate for treatment or retreatment with purine analog based therapy
Able to receive all outpatient treatment and all laboratorial monitoring at the institution that administers program drug
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Farmaceutica Ltda. Clinical Trial | Janssen-Cilag Farmaceutica Ltda. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barretos | Brazil | |||||
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| Florianópolis |
| Brazil |
| Fortaleza | Brazil |
| Porto Alegre | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
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