drugset / Trial / NCT01650701
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
Phase 3
Completed
1030 enrolled
The Lymphoma Academic Research Organisation
Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-02
- Primary completion
- 2017-05-31
- Completion
- 2024-04-30
Outcome
Missed primary endpoint
paper The rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups PMID 30184451 ↗
paper hazard ratio = 1.03 [95% CI, 0.84 to 1.27] PMID 35947804 ↗
Publications
- Gower 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.
- Claudel 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.
- Laurent 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.
- Morschhauser 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.
- Delfau-Larue MH, Boulland ML, Beldi-Ferchiou A, Feugier P, Maisonneuve H, Casasnovas RO, Lemonnier F, Pica GM, Houot R, Ysebaert L, Tilly H, Eisenmann JC, Le Gouill S, Ribrag V, Godmer P, Glaisner S, Cartron G, Xerri L, Salles GA, Fest T, Morschhauser F. Lenalidomide/rituximab induces high molecular response in untreated follicular lymphoma: LYSA ancillary RELEVANCE study. Blood Adv. 2020 Aug 11;4(14):3217-3223. doi: 10.1182/bloodadvances.2020001955.
- Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | — | — |
| Subject | Lenalidomide | Other / unclassified | 10 mg | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |