NCT05429268

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Conditions

• Large B-Cell Lymphoma
• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tafasitamab	Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
DRUG	Lenalidomide	Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

Timeline

• Start date: 2022-12-23
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2022-06-23
• Last updated: 2025-12-10

Locations

61 sites across 14 countries: Bulgaria, Croatia, Czechia, Denmark, Finland, Hungary, Ireland, Israel, Norway, Poland, Romania, Serbia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study