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

men. The primary endpoint of the study is PFS. This global study, conducted by Janssen outside the US, is recruiting and Janssen plans to enroll 280 patients.
  • SHINE (MCL3002): Phase III study of ibrutinib in combination with bendamustine and rituximab in elderly patients with newly diagnosed MCL. 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 patients 65 years or older with newly diagnosed MCL. The primary endpoint of the study is PFS. This global study, conducted by Janssen, is recruiting and Janssen plans to enroll 520 patients.
  • MCL4001: A multicenter, open label Expanded Access Program (EAP) for ibrutinib as a monotherapy in relapsed/refractory (R/R) MCL patients has been initiated in the US by Janssen. EAPs are clinical studies allowed under certain circumstances by the FDA. They are designed to provide a mechanism for access to an investigational drug to treat patients with a serious or immediately life-threatening diseases or conditions until the time of an anticipated U.S. marketing approval. Further information about this program can be found on www.clinicaltrials.gov.
  • DLBCL

  • PCYC-1106: Phase II study of ibrutinib in patients with relapsed or refractory DLBCL. This trial is a multicenter, open-label study 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. This trial is active in several US sites and Pharmacyclics has enrolled 70 patients with updated results most recently published at EHA in June 2013. In July a new cohort with ibrutinib dosed at 840mg in patients with non-GCB subtype DLBCL was initiated. This cohort will increase the enrollment target for this study to 125 patients.
  • DBL1002: Phase Ib dose escalating stu
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