Study on Subcutaneous Epcoritamab With or Without Lenalidomide as First Treatment for Diffuse Large B-Cell Lymphoma

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05660967

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment using epcoritamab, with or without lenalidomide, for elderly patients newly diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot undergo standard chemotherapy.

Patient Parameters

Program Overview

The study aims to find out if epcoritamab, alone or combined with lenalidomide, can help treat elderly patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) who are unable to tolerate standard chemotherapy. Epcoritamab is an antibody that has been tested in other studies. All participants will receive active treatment, with an equal chance of receiving either epcoritamab alone or with lenalidomide.

Description

This is a global phase-2 trial that is open-label, meaning both the researchers and participants know which treatment is being administered. The trial is conducted in multiple centers and is divided into two stages:

  • Stage 1: Includes a safety run-in phase for each treatment group to ensure the treatments are safe.
  • Stage 2: Expands on the treatment selected from Stage 1 to further evaluate its effectiveness and safety in a larger group of patients.

Eligibility Criteria

Inclusion Criteria

  • Must have newly diagnosed CD20+ large cell lymphoma.
  • Cannot undergo standard chemotherapy due to:
    • Being 80 years or older; AND/OR
    • Being 75 years or older with other health conditions that make chemotherapy unsafe.
  • Must have a score of at least 8 out of 10 on a mental function test related to immune cell therapy.
  • Must have cancer that is at Stage II-IV according to the Ann Arbor system.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health, or 3 if the score improves to 2 or less after initial treatment.
  • Must have measurable disease based on specific criteria.
  • Must have acceptable organ function based on blood tests.
  • Must provide a recent or stored biopsy sample at screening.

Exclusion Criteria

  • Have an active, significant infection, including COVID-19.
  • Have severe heart disease that prevents chemotherapy.
  • Have had major surgery within 4 weeks before starting treatment.
  • Have received certain cancer treatments or investigational drugs recently.
  • Have had a stem cell or organ transplant.
  • Have received live vaccines within 30 days before starting treatment.
  • Have a primary brain tumor or known brain involvement.
  • Have a seizure disorder requiring medication or recent seizures.
  • Have another active or past cancer, with some exceptions.
  • Have allergies or intolerance to the trial treatments.
  • Have active hepatitis B or C, alcohol abuse, or liver disease.
  • Have active cytomegalovirus infection needing treatment.
  • Have untreated or active tuberculosis.
  • Have a history of HIV. HIV testing may be required based on local guidelines.

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