The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
199
Dose based on parent protocol
Stanford University
Stanford, California, United States
Unnamed facility
Stanford, California, United States
University of Chicago
Chicago, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
New Hyde Park, New York, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Springfield, Oregon, United States
Unnamed facility
Nashville, Tennessee, United States
...and 6 more locations
Number of Subjects With Adverse Events
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.
Time frame: 30 days after last dose of study drug, continue up to 6 months
Progressive Disease (PD)
A progressive disease confirmed by a CT scan.
Time frame: 30 days after last dose of study drug, continue up to 6 months
Death Event
All death events are due to AE, progressive disease, and other reasons.
Time frame: 30 days after last dose of study drug
Documented Responses
Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.
Time frame: 30 days after last dose of study drug, continue up to 6 months
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