Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3)

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3)

ClinicalTrials.gov ID: NCT05660967
Sponsor: Genmab
Information provided by: Genmab (Responsible Party)
Last Update Posted: 2024-04-03

Brief 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

Official Title:
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

Intervention / Treatment: 
- Biological: Epcoritamab
- Drug: Lenalidomide

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