Haematology 2018

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

CR, CRu, PR

R 2

R 2 maintenance

1st line FL N = 1000

R

CR, CRu, PR

R-Chemo

Rituximab maintenance

6 months

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

ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/show/NCT01650701. Accessed October, 2015