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Pharmacyclics Reports Results for Six and Three Months Ended December 31, 2012
Date:2/14/2013

udy enrolled prior to the fourth quarter of 2013.
  • Phase III study of ibrutinib versus chlorambucil in frontline newly diagnosed elderly CLL/SLL patients, RESONATE™ -2.  This trial is a randomized, multicenter, open-label study of ibrutinib as a monotherapy versus chlorambucil in patients 65 years or older with treatment naïve CLL/SLL. The study design was granted a Special Protocol Assessment (SPA), designed to demonstrate superiority of ibrutinib with the primary endpoint of progression-free survival when compared to chlorambucil. This global study is open and Pharmacyclics plans to enroll 272 patients worldwide. The Company anticipates enrollment for this study will take approximately 18 months to complete. 
  • Phase III study of ibrutinib in combination with bendamustine and rituximab in patients with relapsed or refractory CLL/SLL, HELIOS (CLL3001). This trial is a randomized, multi-center, double blinded, placebo controlled trial of ibrutinib in combination with bendamustine and rituximab in relapsed or refractory CLL/SLL patients who received at least one line of prior systemic therapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival when compared to bendamustine and rituximab. This global study, conducted by Janssen, is open and Janssen plans to enroll 580 patients worldwide.
  • Phase II study, RESONATE™ -17p, which is a single-arm, open-label, multi-center trial using ibrutinib as a monotherapy in patients who have deletion 17p and who did not respond to or relapsed after at least one prior treatment with chemo immunotherapy (a high unmet need population). The primary endpoint of the study will be overall response rate. This global study is open and Pharmacyclics plans to enroll 111 patients worldwide. The Company anticipates enrollment for this study will take approximately 12 months to complete.
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