# RELEVANCE

Source: https://onco.cc/trials/relevance/  
OnCo record `relevance` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Complete 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.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-22
- Also known as: RV-FOL-GELARC-0683C
- Tags: soc-trials
- Registry id: 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
- Enrolled: 1030
- 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.
- Outcomes: Complete or unconfirmed complete response at 120 weeks (independent review): Rituximab + lenalidomide 48% vs Rituximab + chemotherapy 53%; Progression-free survival at 3 years (interim): Rituximab + lenalidomide 77% vs Rituximab + chemotherapy 78%; Progression-free survival, final (registry results): Rituximab + lenalidomide 120.2 months vs Rituximab + chemotherapy 123.8 months, HR 0.92; Grade 3 or 4 neutropenia: Rituximab + lenalidomide 32% vs Rituximab + chemotherapy 50%; Grade 3 or 4 cutaneous reactions: Rituximab + lenalidomide 7% vs Rituximab + chemotherapy 1%

## Sources

- ClinicalTrials.gov NCT01476787: https://clinicaltrials.gov/study/NCT01476787

## Connected records

- cancers: [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Bendamustine](https://onco.cc/drugs/bendamustine/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Lenalidomide](https://onco.cc/drugs/lenalidomide/), [Prednisone](https://onco.cc/drugs/prednisone/), [Rituximab](https://onco.cc/drugs/rituximab/), [Vincristine](https://onco.cc/drugs/vincristine/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- key papers: [RELEVANCE: rituximab plus lenalidomide in advanced untreated follicular lymphoma](https://onco.cc/key-papers/paper-relevance-rituximab-lenalidomide-follicular-lymphoma-morschhauser-nejm-2018/)

---
JSON: https://onco.cc/api/v1/entities/relevance.json