A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

Summary

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

Timeline

Start

2021-04-15

Primary completion

2024-02-23

Completion

2028-08-09

Publications

• Sehn LH, Hubel K, Luminari S, Scholz CW, Salar A, Paneesha S, Wahlin BE, Panayiotidis P, Lee HP, Jimenez-Ubieto A, Sancho JM, Kim TM, Domingo Domenech E, Kumode T, Poh C, Thieblemont C, Deeren D, de Wit E, Arbushites M, Vassallo I, Trneny M; inMIND Study team. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. 2026 Jan 10;407(10524):133-146. doi: 10.1016/S0140-6736(25)01778-7. Epub 2025 Dec 5.

Drugs

Indications