At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line
In Brief
A Phase 3 clinical trial evaluating Lenalidomide and Placebo for Lymphoma and Diffuse Large B-cell Lymphoma. Completed, enrolled 650 participants across 157 sites in 9 countries.
Detailed Summary
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
Study Details
Timeline
Interventions
Daily for 3 weeks every 4 weeks for 24 months
Daily for 3 weeks every 4 weeks for 24 months