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 AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupProtein Kinase InhibitorsChemical SubgroupBruton's Tyrosine Kinase (BTK) InhibitorsCondition StudiedLymphoma, Mantle Cell/Small Lymphocytic
Sponsor Protocol NumberPCI-32765MCL3001Enrollment280Data PartnerJohnson & Johnson% Female25.7%Mean/Median Age (Years)66.9% White87.0%

Supporting Documentation

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

Disclaimer

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