Study Phase 3

A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

Trial Information

Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaCancers and Other NeoplasmsEnrollment280% Female25.7%% White87.0%
Product ClassKinase InhibitorsSponsor Protocol NumberPCI-32765MCL3001Data PartnerJohnson & JohnsonCondition StudiedLymphoma, Mantle Cell/Small LymphocyticMean/Median Age (Years)66.9

Supporting Documentation

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

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