Study on Epcoritamab and Lenalidomide for Treating Difficult or Returning Immunodeficiency-Related Large B-Cell Lymphoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06723457

Provider View

This clinical trial is exploring a new treatment using a combination of epcoritamab and lenalidomide to help patients with large B-cell lymphoma related to immunodeficiency, which has not responded to previous treatments or has returned after improvement.

Patient Parameters

Program Overview

The purpose of this study is to test how well the combination of two drugs, epcoritamab and lenalidomide, works in treating patients with large B-cell lymphoma related to immunodeficiency. This type of lymphoma either does not respond to treatment (refractory) or comes back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that helps the immune system's T-cells target and kill lymphoma cells. Lenalidomide also helps the immune system fight lymphoma. The study aims to see if using both drugs together is more effective in treating this type of lymphoma.

Description

The main goal of this study is to see how well the combination of epcoritamab and lenalidomide works in patients who cannot have chemotherapy and have large B-cell lymphoma related to immunodeficiency that is either refractory or relapsed. Researchers will look at how many patients achieve a complete response after six months of treatment.

Secondary goals include evaluating the overall response rate, which includes partial and complete responses at different time points, and assessing how long the response lasts. The study will also monitor progression-free survival and overall survival over 12, 18, and 24 months. Safety and side effects of the treatment will be closely watched.

Exploratory goals involve studying changes in immune cells and understanding how the treatment affects different immune cell types. Researchers will also use questionnaires to measure symptoms and concerns related to the disease and treatment.

Participants will receive epcoritamab as an injection under the skin weekly during the first cycle, then on specific days in subsequent cycles. Lenalidomide will be taken orally for 21 days of each 28-day cycle, for up to 12 months, unless the disease progresses or side effects become unacceptable. Patients will have regular scans and blood tests throughout the study and may have an MRI during screening. After completing the treatment, follow-up visits will occur at 30 days, then at 12, 18, and 24 months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with immunodeficiency-related large B-cell lymphoma, including certain types related to immune deficiency or Epstein-Barr virus (EBV) infection.
  • Must have measurable disease, with specific size criteria for tumors.
  • Must be ineligible for CAR-T cell therapy and meet certain disease status criteria, such as primary refractoriness or relapse after previous treatment.
  • Aged 18 years or older.
  • Have a performance status score of 0-2, indicating good overall health.
  • Meet specific blood count and organ function requirements.
  • If previously infected with hepatitis B or C, must have controlled or cured infection.
  • Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting the study.
  • No active COVID-19 infection, with specific testing requirements if recently exposed or symptomatic.

Exclusion Criteria

  • Previous treatment with certain types of T-cell engaging therapies.
  • Recent chemotherapy or other cancer treatments, except specific allowed medications.
  • Recent stem cell transplant or CAR-T therapy with relapse.
  • Allergic reactions to similar drugs as those in the study.
  • Uncontrolled HIV infection.
  • Active disease in the central nervous system or uncontrolled seizure disorder.
  • Recent major surgery or significant heart disease.
  • Inability to take oral medications.
  • Recent live vaccine administration.
  • Pregnant or nursing women.
  • Uncontrolled infections or other serious illnesses that could interfere with the study.

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