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

sus temsirolimus in relapsed or refractory  MCL patients, RAY (MCL3001). This trial is a randomized, multi-center, open-label trial of ibrutinib as a mono-therapy versus temsirolimus in relapsed or refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen. The primary endpoint of the study is progression free survival when compared to temsirolimus. This global study, conducted by Janssen outside the US, is open and Janssen plans to enroll 280 patients.
  • Phase III study of ibrutinib in combination with bendamustine and rituximab in patients with newly diagnosed MCL, SHINE (MCL3002). This trial is a randomized, multi-center, double-blinded, placebo-controlled trial of ibrutinib plus bendamustine and rituximab versus placebo plus bendamustine and rituximab in subjects with newly diagnosed MCL. The primary endpoint of the study is progression free survival when compared to bendamustine and rituximab. Janssen plans to enroll 520 patients in this study.
  • Phase II study of ibrutinib in patients with mantle cell lymphoma who progress after bortezomib therapy, SPARK (MCL2001). This is a single-arm, multi-center trial of ibrutinib as a monotherapy in relapsed or refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is overall response rate. This global study, conducted by Janssen, is open and Janssen plans to enroll 110 patients worldwide.
  • Phase II study of ibrutinib in patients with mantle cell lymphoma who progress after bortezomib therapy, SPARK (MCL2001). This is a single-arm, multi-center trial of ibrutinib as a monotherapy in relapsed or refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. The primary endpoint of the study is overall response rate. This global study, conducted by Janssen,
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