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Pharmacyclics Reports Third Quarter 2013 Results
Date:11/7/2013

iffuse large B-cell lymphoma (DLBCL). This multicenter, open-label trial designed to assess the activity of ibrutinib in two genetically distinct subtypes of DLBCL, the activated B-cell (ABC) subtype and the germinal center B-cell (GCB) subtype started in the second quarter of 2011. This trial is active in several US sites and Pharmacyclics has enrolled 70 patients with updated results most recently published at the Annual Meeting of the European Hematology Association in June of 2013. In July of 2013 a new cohort with ibrutinib dosed at 840mg in patients with non-GCB subtype DLBCL was initiated. Pharmacyclics is currently enrolling patients in this new cohort.
  • DBL1002: Phase Ib dose escalating study of ibrutinib in combination with R-CHOP in patients with newly diagnosed CD20 positive B-cell Non Hodgkin Lymphoma (DLBCL, MCL, FL) started in the second quarter of 2012. The purpose of this study is to identify a safe and tolerable dose of ibrutinib in combination with R-CHOP. This global, multi-center study has been fully accrued with 17 patients and an update on the dose escalating phase of this study was provided at ASCO 2013. With a recommended Phase II dose established, an additional 15 patients with newly diagnosed DLBCL enrolled in the study. DBL1002 is currently in the follow up phase.
  • DBL3001: Phase III study of ibrutinib in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with newly diagnosed the non-GCB subtype of DLBCL started in the third quarter of 2013. This is a randomized, multi-center, double-blinded, controlled trial of ibrutinib plus R-CHOP versus R-CHOP in patients with newly diagnosed non-GCB subtype DLBCL. The primary endpoint of the study is to demonstrate a clinically significant improvement in event-free survival when compared to R-CHOP. The enrollment target of this global study is 800 patients.
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  • FLR2002: Phase II study of ibrutinib in pat
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  • SOURCE Pharmacyclics, Inc.
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