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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2017

At a glance

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

    • 05 Dec 2017 According to a Janssen Research & Development media release, An Independent Data Monitoring Committee (IDMC) recommended unblinding the study data, based on efficacy results observed in the pre-specified interim analysis. The company will share and discuss the unblinded data from the study with health authorities around the world.
    • 05 Dec 2017 Primary endpoint has been met. (Progression-free survival), according to a Janssen Research & Development media release.
    • 25 Jun 2017 Results of sub-study (patients with RTX-refractory WM) presented at the 22nd Congress of the European Haematology Association
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