Study Phase 3

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

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsCondition StudiedLeukemia, Chronic LymphocyticChemical SubgroupsN/APharmacological SubgroupsN/A
Sponsor Protocol NumberPCI-32765CLL3002Enrollment159Data PartnerJohnson & Johnson% Female27.4%Mean/Median Age (Years)63.6% White13.8%

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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