At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
Ibrutinib +3 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.
A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician's Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants With Relapsed or Refractory Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Ibrutinib, Lenalidomide, and 2 other interventions for Lymphoma, Mantle-Cell. Completed, enrolled 36 participants across 66 sites in 13 countries.
Detailed Summary
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Mantle-Cell
CountriesBrazil, Czechia, Greece, India, Malaysia, Poland, Puerto Rico, Romania, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye)
CollaboratorsPharmacyclics LLC.
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartDec 2022
Primary CompletionDec 2023
Study CompletionSep 2024
TodayJul 2026
First PostedOct 3, 2022
Enrollment StartDec 6, 2022
Primary CompletionDec 6, 2023
Study CompletionSep 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 3.7 years ago
Interventions
Ibrutinibdrug
Ibrutinib capsules will be administered orally.
Lenalidomidedrug
Lenalidomide capsules will be administered orally.
Rituximabdrug
Rituximab will be administered IV.
Bortezomibdrug
Bortezomib will be administered either intravenously or subcutaneously.