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: 21 Jan 2025

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At a glance

27 Feb 2023 According to a Janssen Pharma K.K. media release, based on results from clinical studies (iNNOVATE, PCYC-1118E and WAL2002 study) an application was filed for a partial change in manufacturing and marketing approval for indication of "primary macroglobulinemia and lymphoplasmacytic lymphoma".
04 Oct 2021 Results final analysis published in the Journal of Clinical Oncology
11 Aug 2021 Results (N=31), of a final analysis of sub-study of single-agent ibrutinib in patients with rituximab-refractory WM, representing up to 5 years of follow-up, an additional 40 months since the first report published in the Clinical Cancer Research

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