756 / 1631
RELEVANCE: A Lymphoma Study Association Trial
RELEVANCE is a prospective, randomized, phase 3 trial comparing the efficacy of the R
2
regimen versus R-CHEMO
followed by rituximab maintenance in patients with treatment-naive FL
1st line FL
N = 1000
R
2
maintenance
Rituximab maintenance
R
12 months
Co-primary endpoints: CR/CRu at 120 weeks and PFS
R-Chemo
• Investigator choice of R-CHOP, R-CVP, R-B
R
2
• Lenalidomide 20-mg QD x 6 cycles (days 2-22 of 28-day cycle). If a CR is achieved at
6 months then 10-mg QD x 12 cycles; if PR, then additional 3-6 cycles of lenalidomide 20-mg
• Rituximab weekly x 4, then on day 1 of each cycle 2 to cycle 6, then every other cycle
R
2
R-Chemo
6 months
CR, CRu, PR
CR, CRu, PR
ClinicalTrials.gov.
http://www.clinicaltrials.gov/ct2/show/NCT01650701.Accessed October, 2015