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Pharmacyclics Reports First Quarter 2013 Results
Date:5/1/2013

SPARK (MCL2001). This is a single-arm, multi-center trial of ibrutinib as a monotherapy in R/R 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, which is scheduled to be evaluated 6 months from the completion of enrollment.  This global study, conducted by Janssen has completed enrollment of the planned 110 patients in April of 2013.
  • 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). The purpose of this study is to identify a safe and tolerable dose of ibrutinib in combination with R-CHOP. With a recommended Phase II dose established, the study is currently in the expansion phase in patients with newly diagnosed DLBCL. This global, multi-center study, conducted by Janssen, has been fully accrued. An update on the dose escalating phase of this study will be provided at ASCO, 2013.
  • Phase II study of ibrutinib in patients with R/R MM. This is a Phase II, multi-center, open-label trial designed trial to assess the safety and efficacy of ibrutinib single agent and in combination with dexamethasone in patients with R/R MM. This study is conducted by Pharmacyclics and is currently exploring ibrutinib administration at 560 mg in combination with dexamethasone. Two further cohorts are planned to be explored; 840 mg with dexamethasone and 840 mg as a single agent. Pharmacyclics anticipates an update on this program will be provided by year end 2013.
  • 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 ob
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