An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
145
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Overall Response Rate
The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
Time frame: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Number of Participants With Treatment Emergent Adverse Events (AEs)
Number of participants who had experienced at least one treatment emergent AE
Time frame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
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Phoenix, Arizona, United States
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Duarte, California, United States
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Greenbrae, California, United States
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La Jolla, California, United States
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Stanford, California, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
...and 45 more locations