NCT05660967

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Detailed description

This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients who are deemed anthracycline ineligible. The trial is designed in two stages: * Stage 1 which includes a safety run-in phase in each arm * Stage 2, an expansion of the selected treatment from Stage 1

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Epcoritamab	Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.
DRUG	Lenalidomide	Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.

Timeline

• Start date: 2023-03-06
• Primary completion: 2026-06-14
• Completion: 2026-06-28
• First posted: 2022-12-21
• Last updated: 2026-04-08

Locations

74 sites across 12 countries: United States, Austria, Belgium, Czechia, France, Germany, Italy, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study