Study Phase 3

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaCancers and Other NeoplasmsEnrollment523% Female30.4%% White77.4%
Product ClassKinase InhibitorsSponsor Protocol NumberPCI-32765MCL3002Data PartnerJohnson & JohnsonCondition StudiedLymphoma, Mantle Cell/Small LymphocyticMean/Median Age (Years)71.0

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

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