Clinical trial · Interventional
A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma
A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA The "RELEVANCE" Trial (Rituximab Lenalidomide Versus ANy ChEmotherapy)is Being Conducted as Two Companion Studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the Combined Total of 1000 Patients Enrolled in Both Studies Will be Analyzed.
NCT01650701CI-TRIAL-00095782RELEVANCEcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Rituximab - Bendamustine | Drug | — | UNRESOLVED |
| Rituximab - CHOP | Drug | — | UNRESOLVED |
| Rituximab - CVP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lenalidomide + Rituximab
- description
- * Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3\~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles * Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
- interventionNames
- Drug: Rituximab
- Drug: Lenalidomide
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- • ONE of the following: Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
- interventionNames
- Drug: Rituximab - CHOP
- Drug: Rituximab - CVP
- Drug: Rituximab - Bendamustine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a * Have no prior systemic treatment for lymphoma. * Must be in need of treatment * Bi-dimensionally measurable disease with at least one mass lesion \> 2 cm that was not previously irradiated. * Stage II, III or IV disease. * Must be ≥ 18 years and sign an informed consent. * Performance status ≤ 2 on the ECOG scale. * Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) * Willing to follow pregnancy precautions Exclusion Criteria: * Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma. * Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to \< 10 mg/day prednisone (over these 4 weeks). * Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent. * Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV). * Life expectancy \< 6 months. * Known sensitivity or allergy to murine products. * Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years. * Prior use of lenalidomide. * Neuropathy \> Grade 1. * Presence or history of CNS involvement by lymphoma. * Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis. * serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) \> 3x upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma * total bilirubin \> 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma * creatinine clearance of \< 30 mL/min * Pregnant or lactating females. * Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.
References
Publications (6)
- DERIVEDGower N, Feugier P, Westin J, Schiano De Colella JM, Tilly H, Palomba ML, Julia E, Damaj GL, Durand A, Flinn I, Lemonnier F, Morineau N, Ysebaert L, Bartlett N, Thieblemont C, Ribrag V, Gastinne T, Dony A, Fouillet L, Guidez S, Houot R, Da Silva MG, Barnes J, Bijou F, Cartron G, Garcia-Sancho AM, Eradat H, Cheminant M, Guillermo AL, Abrisqueta P, Abraham J, Sarkozy C, Izutsu K, Crochet G, Sehn LH, Gkasiamis A, Yge ML, Chartier L, Fowler N, Xerri L, Salles G, Morschhauser F. Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis. Blood. 2026 Jun 18;147(25):3061-3068. doi: 10.1182/blood.2026033126. PMID 41915772
- DERIVEDClaudel A, Cottereau AS, Bachy E, Itti E, Feugier P, Rossi C, Lemonnier F, Camus V, Daguindau N, Cartron G, Nicolas-Virelizier E, Mboumba DL, Cardoso C, Bommier C, Tessoulin B, Fruchart C, Gilbert A, Durot E, Fleck E, Pica GM, Zerazhi H, Guidez S, Cheminant M, Sarkozy C, Xerri L, Vercellino L, Trabelsi N, Gomes L, Portugues C, Viailly PJ, Delfau-Larue MH, Morschhauser F. Combined PET and ctDNA response as a predictor of POD24 for follicular lymphoma after first-line induction treatment. Blood. 2025 Aug 21;146(8):913-925. doi: 10.1182/blood.2024027727. PMID 40499012
- DERIVEDLaurent C, Trisal P, Tesson B, Seth S, Beyou A, Roulland S, Lesne B, Van Acker N, Cerapio JP, Chartier L, Guille A, Stokes ME, Huang CC, Huet S, Gandhi AK, Morschhauser F, Xerri L. Follicular lymphoma comprises germinal center-like and memory-like molecular subtypes with prognostic significance. Blood. 2024 Dec 12;144(24):2503-2516. doi: 10.1182/blood.2024024496. PMID 39374535
- DERIVEDMorschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, Bachy E, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Le Gouill S, Daguindau N, Guidez S, Pica GM, Garcia-Sancho AM, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Kalung W, Sehn LH, Izutsu K, Cartron G, Gkasiamis A, Crowe R, Xerri L, Fowler NH, Salles G. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022 Oct 1;40(28):3239-3245. doi: 10.1200/JCO.22.00843. Epub 2022 Aug 10.