Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+
Status:
Completed
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous
Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in
patients aged 80 years old or more with not previously treated cluster of differentiation
antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival
(OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the
R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The
statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of
the experimental arm, as compared to the reference arm (R-miniCHOP).