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: 01 Mar 2024
Price :
$35
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At a glance
- Drugs Ibrutinib (Primary) ; Rituximab (Primary)
- Indications Waldenstrom's macroglobulinaemia
- Focus Registrational; Therapeutic Use
- Acronyms iNNOVATE
- Sponsors Pharmacyclics
- 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