CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 358 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Rituximab 375mgfrom 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.

Search/NCT01938001
NCT01938001Phase 3Completed
CompareCT.gov

A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma

Celgene·interventional·Posted Sep 10, 2013·Updated Feb 22, 2023

In Brief

A Phase 3 clinical trial evaluating Rituximab, Lenalidomide, and 1 other intervention for Lymphoma, Non-Hodgkin. Completed, enrolled 358 participants across 160 sites in 17 countries.

Detailed Summary

This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin
CountriesBelgium, Brazil, China, Czechia, France, Germany, Israel, Italy, Japan, Poland, Portugal, Puerto Rico, Russia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 10, 2013
Enrollment StartNov 21, 2013
Primary CompletionJun 22, 2018
Study CompletionJan 26, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.8 years ago

Interventions

Rituximabdrug

Rituximab 375mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28 day cycle from Cycles 2 to 5

Lenalidomidedrug

Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles

Placebodrug

Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days