At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 280 enrolled
Drug / intervention
Ibrutinib +1 moredrug
Likely dose
Ibrutinib 560 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.
A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
In Brief
A Phase 3 clinical trial evaluating Ibrutinib and Temsirolimus for Mantle Cell Lymphoma. Completed, enrolled 280 participants across 92 sites in 21 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle Cell Lymphoma
CountriesBelgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hungary, Ireland, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom
CollaboratorsPharmacyclics LLC.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartDec 2012
Primary CompletionJun 2015
Study CompletionDec 2016
TodayJul 2026
First PostedJul 20, 2012
Enrollment StartDec 10, 2012
Primary CompletionJun 5, 2015
Study CompletionDec 15, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.0 years ago
Interventions
Ibrutinibdrug
560 mg once daily continuous (without interruption) by mouth for 21-day cycles
Temsirolimusdrug
175 mg once daily intravenous infusion on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each 21-day cycle