Study Phase 3

Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaCancers and Other NeoplasmsEnrollment578% Female33.9%% White91.3%
Product ClassKinase InhibitorsSponsor Protocol NumberPCI-32765CLL3001Data PartnerJohnson & JohnsonCondition StudiedLeukemia, Chronic LymphocyticMean/Median Age (Years)63.5

Supporting Documentation

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

Approved Data Requests Associated with this Trial

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