At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 366 enrolled
Drug / intervention
Ibrutinib +2 moredrug
Likely dose
Not stated in 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.
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
In Brief
A Phase 3 clinical trial evaluating Ibrutinib, Venetoclax, and 1 other intervention for Mantle-Cell Lymphoma. Completed, enrolled 366 participants across 120 sites in 17 countries.
Detailed Summary
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle-Cell Lymphoma
CountriesAustralia, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartJun 2017
Primary CompletionJun 2024
Study CompletionJun 2024
TodayJul 2026
First PostedApr 13, 2017
Enrollment StartJun 19, 2017
Primary CompletionJun 26, 2024
Study CompletionJun 27, 2024
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 9.2 years ago
Interventions
Ibrutinibdrug
Administered orally once daily
Venetoclaxdrug
Administered orally once daily
Placebo Oral tablet to match Venetoclaxdrug
Administered orally once daily