Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Timeline

Start

2021-05-11

Primary completion

2026-09-01

Completion

2027-11-01

Publications

• Lenz G, Trneny M, Burke JM, Nowakowski GS, Fox CP, Chiappella A, Duell J, Jeon YW, Cheah CY, Westin J, Ye JZ, Caguioa PB, Belada D, Shin HJ, Oh SY, Amorim S, Ku M, Mocikova H, Jimenez JL, Gaidano G, Rosenwald A, Chiarle R, Colucci P, Ioannidis S, Cheng L, Vitolo U; frontMIND Study Investigators. Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2528-2541. doi: 10.1016/S0140-6736(26)00866-4. Epub 2026 May 30.
• Jelicic J, Juul-Jensen K, Bukumiric Z, Runason Simonsen M, Roost Clausen M, Ludvigsen Al-Mashhadi A, Schou Pedersen R, Poulsen CB, Gang AO, Brown P, El-Galaly TC, Stauffer Larsen T. International Prognostic Models as Tools for Selection of Higher-risk Trial-eligible Patients With Diffuse Large B-Cell lymphoma. Clin Lymphoma Myeloma Leuk. 2026 Jan;26(1):e62-e76. doi: 10.1016/j.clml.2025.08.020. Epub 2025 Sep 3.
• Belada D, Kopeckova K, Bergua Burgues JM, Stevens D, Andre M, Persona EP, Pichler P, Staber PB, Trneny M, Duell J, Waldron-Lynch M, Wagner S, Mukhopadhyay A, Dirnberger-Hertweck M, Burke JM, Nowakowski GS. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. Blood. 2023 Oct 19;142(16):1348-1358. doi: 10.1182/blood.2023020637.

Drugs

Indications