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Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
Date:6/19/2013

emissions lasting in excess of two years in the great majority of patients treated."  

Study participants were enrolled selected to receive either ibrutinib 420 mg (n=51) or 840 mg (n=34) as a once-daily, oral monotherapy. Both doses were associated with overall response rates of 71 percent. Del17p patients had an overall response rate of 68 percent. Two patients in the 420 mg dose arm had complete responses and 34 patients had partial responses. Across all relapsed or refractory patients, including the high risk patients, the estimated progression-free survival at 26 months was 75 percent. An additional 20 percent of patients treated with the 420 mg dose and 15 percent of patients taking the 840 mg dose achieved a partial response accompanied by lymphocytosis, an elevated blood lymphocyte count.

The majority of adverse events (AEs) observed in the study were considered to be Grade 1 or 2 in severity, including diarrhea, infections and fatigue. A total of six patients taking ibrutinib experienced an AE leading them to discontinue treatment with the drug. Severe AEs observed during the treatment period include pneumonia and dehydration (12 percent and six percent, respectively), as well anemia, neutropenia and thrombocytopenia (six percent, 15 percent and six percent, respectively). Grade 3-4 hematological toxicities were not common.

Data from this study were presented at the annual meeting of the American Society of Hematology in December 2012.

Study Design
The Phase 1b/2, open-label, multicenter study was designed to determine the safety, efficacy, pharmacokinetics and pharmacodynamics of ibrutinib in patients with relapsed or refractory CLL. The primary objective of the study was to determine the safety of the two fixed-dose regimens of ibrutinib, assessed by evaluating the frequency and severity of AEs. Secondary efficacy endpoints included: overall response rate, progression-free survival and an exploratory endpoint of overa
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SOURCE Pharmacyclics, Inc.
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