At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 503 enrolled
Drug / intervention
Lenalidomide +1 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 Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab Maintenance in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma
In Brief
A Phase 3 clinical trial evaluating Lenalidomide and Rituximab for Lymphoma, Non-Hodgkin. Completed, enrolled 503 participants across 126 sites in 3 countries.
Detailed Summary
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin
CountriesGermany, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartApr 2014
Primary CompletionMay 2024
Study CompletionSep 2024
TodayJul 2026
First PostedNov 27, 2013
Enrollment StartApr 1, 2014
Primary CompletionMay 11, 2024
Study CompletionSep 17, 2024
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 12.6 years ago
Interventions
Lenalidomidedrug
Rituximabdrug