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 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupProtein Kinase InhibitorsChemical SubgroupBruton's Tyrosine Kinase (BTK) InhibitorsCondition StudiedLymphoma
Sponsor Protocol NumberPCI-32765DBL3001Enrollment838Data PartnerJohnson & Johnson% Female46.7%Mean/Median Age (Years)62.0% White58.2%

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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