Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
Participant gender:
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.