{"entity":{"id":"relevance","kind":"trial","name":"RELEVANCE","aka":["RV-FOL-GELARC-0683C"],"tldr":"RELEVANCE tested whether a chemotherapy-free combination of rituximab and the pill lenalidomide could beat standard chemo-immunotherapy for untreated follicular lymphoma; it was not better, but it was just as effective with a different set of side effects, so it became an accepted alternative.","summary":"RELEVANCE was an open-label phase 3 superiority trial run by Celgene with the French LYSA group that randomised 1,030 patients with previously untreated follicular lymphoma to rituximab plus lenalidomide or rituximab plus chemotherapy (R-CHOP in most), each followed by rituximab maintenance. The co-primary endpoints were confirmed or unconfirmed complete response at 120 weeks by independent review and progression-free survival.\n\nComplete response at 120 weeks was 48 percent with rituximab-lenalidomide against 53 percent with rituximab-chemotherapy, and interim three-year progression-free survival was 77 against 78 percent, so superiority was not shown. In the final registry results median progression-free survival was 120.2 against 123.8 months (hazard ratio 0.92). Grade 3 or 4 neutropenia and febrile neutropenia were more common with chemotherapy and grade 3 or 4 skin reactions with lenalidomide. The corpus's follicular lymphoma page lists lenalidomide-rituximab as an alternative first-line option on this evidence.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01476787","url":"https://clinicaltrials.gov/study/NCT01476787"}],"tags":["soc-trials"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lenalidomide","rituximab","bendamustine","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-relevance-rituximab-lenalidomide-follicular-lymphoma-morschhauser-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01476787","phase":"3","setting":"Previously untreated advanced follicular lymphoma needing treatment: rituximab plus lenalidomide (R2) against rituximab plus the investigator's chemotherapy (R-CHOP, R-CVP or R-bendamustine), both followed by rituximab maintenance, with complete response at 120 weeks and progression-free survival as co-primary endpoints","sponsor":"Celgene","result":"Complete response at 120 weeks 48 percent with rituximab-lenalidomide against 53 percent with rituximab-chemotherapy (p 0.13) and median progression-free survival 120.2 against 123.8 months (hazard ratio 0.92): not superior, with similar efficacy and a different safety profile.","yearReported":2018,"enrolled":1030,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete or unconfirmed complete response at 120 weeks (independent review)","primary":true,"unit":"%","arms":[{"name":"Rituximab + lenalidomide","n":513,"value":48,"note":"95% CI 44 to 53"},{"name":"Rituximab + chemotherapy","n":517,"value":53,"note":"95% CI 49 to 57"}],"p":"0.13","source":"https://doi.org/10.1056/NEJMoa1805104"},{"endpoint":"Progression-free survival at 3 years (interim)","primary":true,"unit":"%","arms":[{"name":"Rituximab + lenalidomide","n":513,"value":77,"note":"95% CI 72 to 80"},{"name":"Rituximab + chemotherapy","n":517,"value":78,"note":"95% CI 74 to 82"}],"source":"https://doi.org/10.1056/NEJMoa1805104"},{"endpoint":"Progression-free survival, final (registry results)","primary":true,"unit":"months","arms":[{"name":"Rituximab + lenalidomide","value":120.2,"note":"95% CI 104.9 to 126.3"},{"name":"Rituximab + chemotherapy","value":123.8,"note":"95% CI 107.4 to not reached"}],"hr":0.92,"ci":[0.756,1.12],"p":"0.406","source":"https://clinicaltrials.gov/study/NCT01476787?tab=results"},{"endpoint":"Grade 3 or 4 neutropenia","unit":"%","arms":[{"name":"Rituximab + lenalidomide","value":32},{"name":"Rituximab + chemotherapy","value":50}],"source":"https://doi.org/10.1056/NEJMoa1805104"},{"endpoint":"Grade 3 or 4 cutaneous reactions","unit":"%","arms":[{"name":"Rituximab + lenalidomide","value":7},{"name":"Rituximab + chemotherapy","value":1}],"source":"https://doi.org/10.1056/NEJMoa1805104"}]},"route":"/trials/relevance/","neighbours":{"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"bendamustine","kind":"drug","name":"Bendamustine","route":"/drugs/bendamustine/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"lenalidomide","kind":"drug","name":"Lenalidomide","route":"/drugs/lenalidomide/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"paper":[{"id":"paper-relevance-rituximab-lenalidomide-follicular-lymphoma-morschhauser-nejm-2018","kind":"paper","name":"RELEVANCE: rituximab plus lenalidomide in advanced untreated follicular lymphoma","route":"/key-papers/paper-relevance-rituximab-lenalidomide-follicular-lymphoma-morschhauser-nejm-2018/"}]}}