Study Phase 3

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupProtein Kinase InhibitorsChemical SubgroupBruton's Tyrosine Kinase (BTK) InhibitorsCondition StudiedLeukemia, Chronic Lymphocytic
Sponsor Protocol NumberPCYC-1112-CAEnrollment391Data PartnerJohnson & Johnson% Female32.0%Mean/Median Age (Years)66.5% WhiteN/A

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

Disclaimer

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