An expanded access record providing PCI-32765 (Ibrutinib) in B-cell Chronic Lymphocytic Leukemia, sponsored by Janssen-Cilag Farmaceutica Ltda.. Approved for marketing at 7 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-20.
Sponsored by Janssen-Cilag Farmaceutica Ltda. · Expanded access
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.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
Browse Leukemia studies →Janssen-Cilag Farmaceutica Ltda. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Has a diagnosis of Chronic Lymphocytic Leukemia (CLL) that meets published diagnostic criteria (Hallek 2008):
Exclusion Criteria:
Participants will receive PCI-32765 (ibrutinib) 420 mg (three 140-mg capsules) oral once daily continuously on a 28-day cycle.
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Janssen-Cilag Farmaceutica Ltda.