At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 181 enrolled
Drug / intervention
Ibrutinib +2 moredrug
Likely dose
Ibrutinib 420 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ibrutinib, Placebo, and 1 other intervention for Waldenström's Macroglobulinemia. Completed, enrolled 181 participants across 48 sites in 9 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenström's Macroglobulinemia
CountriesAustralia, Canada, France, Germany, Greece, Italy, Spain, United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJul 2014
Primary CompletionNov 2019
TodayJul 2026
First PostedJun 17, 2014
Enrollment StartJul 7, 2014
Primary CompletionNov 7, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.0 years ago
Interventions
Ibrutinibdrug
Participants will receive 420 mg of Ibrutinib orally.
Placebodrug
Participants will receive placebo capsules orally.
Rituximabdrug
Participants will receive rituximab 375 mg/m\^2 IV.