At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 445 enrolled
Drug / intervention
Ibrutinib Oral Capsule +2 moredrug
Likely dose
Ibrutinib Oral Capsule 560mgfrom 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.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
In Brief
A Phase 3 clinical trial evaluating Ibrutinib Oral Capsule, Placebo, and 1 other intervention for Follicular Lymphoma. Completed, enrolled 445 participants across 128 sites in 19 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Russia, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartJan 2017
Primary CompletionFeb 2024
Study CompletionJun 2025
TodayJul 2026
First PostedOct 27, 2016
Enrollment StartJan 23, 2017
Primary CompletionFeb 21, 2024
Study CompletionJun 9, 2025
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 9.7 years ago
Interventions
Ibrutinib Oral Capsuledrug
Ibrutinib 560mg administered orally daily
Placebodrug
Placebo capsules to match ibrutinib administered orally daily
Rituximabdrug
Rituximab 375mg/m\^2 intravenously (IV) weekly