Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP

Summary

This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.

Timeline

Start

2009-04

Primary completion

2016-06

Completion

2019-09

Publications

• Montagne A, Bertho G, Papastergiou T, Chartier L, Ricci R, Jardin F, Ghesquieres H, Rossi C, Morschhauser F, Haioun C, Ribrag V, Feugier P, Brisou G, Oberic L, Gaulard P, Giraud N, Bennani Y, Thieblemont C, Baud V. Risk stratification of patients with diffuse large B-cell lymphoma using plasma NMR-based metabolomics at diagnosis. Blood Adv. 2026 Jan 27;10(2):358-366. doi: 10.1182/bloodadvances.2025017248.
• Beldi-Ferchiou A, Jais JP, Ghesquieres H, Casasnovas RO, Tilly H, Fruchart C, Morschhauser F, Haioun C, Lazarovici J, Perrot A, Nicolas-Virelizier E, Salles G, Godard N, Zamali I, De Colella JS, Claudel A, Corront B, Oberic L, Briere J, Gaulard P, Thieblemont C, Delfau-Larue MH. Lenalidomide maintenance fails to overcome the unfavourable prognosis of low NK-cell counts in rituximab-chemotherapy responsive elderly DLBCL patients: A LYSA group study. Br J Haematol. 2023 Apr;201(2):256-266. doi: 10.1111/bjh.18642. Epub 2023 Feb 6.
• Girum KB, Rebaud L, Cottereau AS, Meignan M, Clerc J, Vercellino L, Casasnovas O, Morschhauser F, Thieblemont C, Buvat I. 18F-FDG PET Maximum-Intensity Projections and Artificial Intelligence: A Win-Win Combination to Easily Measure Prognostic Biomarkers in DLBCL Patients. J Nucl Med. 2022 Dec;63(12):1925-1932. doi: 10.2967/jnumed.121.263501. Epub 2022 Jun 16.
• Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, Vercellino L, Casasnovas O, Thieblemont C, Buvat I. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CTdagger. Ann Oncol. 2021 Mar;32(3):404-411. doi: 10.1016/j.annonc.2020.11.019. Epub 2020 Dec 3.
• Vercellino L, Cottereau AS, Casasnovas O, Tilly H, Feugier P, Chartier L, Fruchart C, Roulin L, Oberic L, Pica GM, Ribrag V, Abraham J, Simon M, Gonzalez H, Bouabdallah R, Fitoussi O, Sebban C, Lopez-Guillermo A, Sanhes L, Morschhauser F, Trotman J, Corront B, Choufi B, Snauwaert S, Godmer P, Briere J, Salles G, Gaulard P, Meignan M, Thieblemont C. High total metabolic tumor volume at baseline predicts survival independent of response to therapy. Blood. 2020 Apr 16;135(16):1396-1405. doi: 10.1182/blood.2019003526.

Drugs

Indications