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 AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupProtein Kinase InhibitorsChemical SubgroupBruton's Tyrosine Kinase (BTK) InhibitorsCondition StudiedLymphoma, Mantle Cell/Small Lymphocytic
Sponsor Protocol NumberPCI-32765MCL3002Enrollment523Data PartnerJohnson & Johnson% Female30.4%Mean/Median Age (Years)71.0% White77.4%

Supporting Documentation

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

Approved Data Requests Associated with this Trial

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