ROBUST
Clinical Study Design: Phase III double blind
DLBCL
Select by
GEP
ABC
6 x R-CHOP21 + Lenalidomide 15 mg x 14*
n=280
6 x R-CHOP21 + Placebo x 14*
n=280
GCB,
unclassified
Ineligible
R
*
Option for 2 additional rituximab doses after completing
treatment regimen (if considered standard of care per
local practice
)
▪
Newly diagnosed DLBCL of ABC type
▪
IPI ≥ 2; ECOG PS ≤ 2; Age 18–80
▪
Primary Endpoint = PFS
▪
N = 560
ClinicalTrials.gov.NCT02285062