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iNNOVATE Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenstrom's Macroglobulinemia

Trial Profile

iNNOVATE Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenstrom's Macroglobulinemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2020

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At a glance

  • Drugs Ibrutinib (Primary) ; Rituximab (Primary)
  • Indications Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms iNNOVATE
  • Sponsors Pharmacyclics
  • Most Recent Events

    • 23 Jun 2020 According to an AbbVie media release, results from the long-term analysis of this Phase 3 iNNOVATE study will be presented at a future medical congress.
    • 23 Jun 2020 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the treatment of Waldenstroms macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). The application seeks to update the IMBRUVICA U.S. Prescribing Information based on analysis of more than five years of data from the Phase 3 iNNOVATE clinical trial.
    • 19 Feb 2020 Status changed from active, no longer recruiting to completed.
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