Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study. Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
297
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Time frame: Up to 3 years and will be re-evaluated on an ongoing basis.
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Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
Burbank, California, United States
City Of Hope National Medical Center
Duarte, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Norton Medical Plaza II, 3991 Dutchmans Lane
Louisville, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
...and 88 more locations