At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 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 Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
In Brief
A Phase 2 clinical trial evaluating Ibrutinib and rituximab for Follicular Lymphoma and 2 related conditions. Completed, enrolled 80 participants across 12 sites.
Detailed Summary
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma, B-cell Lymphoma, Non-Hodgkin's Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartDec 2013
Primary CompletionNov 2017
TodayJul 2026
First PostedNov 11, 2013
Enrollment StartDec 1, 2013
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.6 years ago
Interventions
Ibrutinibdrug
All subjects will receive 560 mg of Ibrutinib orally.
rituximabdrug
All subjects will receive rituximab 375 mg/m2 intravenously