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Pharmacyclics Reports Second Quarter 2013 Results
Date:7/31/2013

dy of ibrutinib in combination with R-CHOP in patients with newly diagnosed CD20 positive B-cell Non Hodgkin Lymphoma (DLBCL, MCL, FL). 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, conducted by Janssen, 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, the study has enrolled additional 15 patients with newly diagnosed DLBCL and is currently in the expansion phase.
  • DBL3001: Phase III study of ibrutinib in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with newly diagnosed non-germinal center B-cell subtype of DLBCL. This trial 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. This global study, conducted by Janssen, is not yet recruiting and Janssen plans to enroll 800 patients worldwide.
  • FL

  • FLR2002: Phase II study of ibrutinib in patients with R/R follicular lymphoma (FL). This is a multi-center, global study of ibrutinib in patients with chemoimmunotherapy-resistant FL, whose disease has relapsed from at least 2 prior lines of therapy, including at least 1 rituximab combination chemotherapy regimen. The primary endpoint of this study is objective response rate. This global study, conducted by Janssen, is recruiting and Janssen plans to enroll 110 patients.
  • WM

  • NCI STUDY: Phase II study of ibrutinib in patients with R/R WM. This is a multicenter, open label study with a primary endpoint of ORR and is currently exploring ibrutinib administration at 420 mg in patients with WM who have failed at least 1 prior thera
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  • SOURCE Pharmacyclics, Inc.
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