CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 570 enrolled
Drug / intervention
lenalidomide +6 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.

Search/NCT02285062
NCT02285062Phase 3Completed
CompareCT.gov

Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

Celgene·interventional·Posted Nov 6, 2014·Updated Jun 22, 2023

In Brief

A Phase 3 clinical trial evaluating lenalidomide, Placebo, and 5 other interventions for Lymphoma, Large B-Cell, Diffuse. Completed, enrolled 570 participants across 158 sites in 21 countries.

Detailed Summary

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Large B-Cell, Diffuse
CountriesAustralia, Belgium, Canada, China, Czechia, France, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 6, 2014
Enrollment StartFeb 17, 2015
Primary CompletionMar 15, 2019
Study CompletionJul 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.7 years ago

Interventions

lenalidomidedrug

Placebodrug

Rituximabdrug

Cyclophosphamidedrug

Doxorubicindrug

prednisonedrug

vincristinedrug