Study on Epcoritamab, Zanubrutinib, and Rituximab for Treating Relapsed or Refractory Follicular Lymphoma

Sponsor: Reid Merryman, MD

Sponsor score: 0

ClinicalTrials ID:NCT06563596

Provider View

This clinical trial is testing a combination of three drugs—Epcoritamab, Zanubrutinib, and Rituximab—to see if they are safe and effective in treating patients with follicular lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out how well a combination of three drugs—Epcoritamab, Zanubrutinib, and Rituximab—works in treating people with follicular lymphoma that has come back or not responded to other treatments. Epcoritamab and Rituximab are types of antibodies, while Zanubrutinib is a drug that targets specific proteins in cancer cells. Participants will receive these treatments for about 24 months and will be monitored every 6 months for up to 10 years. The study involves various tests and procedures, including blood tests, scans, and questionnaires, to ensure the safety and effectiveness of the treatment.

Description

This study is open to people with follicular lymphoma that has returned or not responded to previous treatments. It will test the safety and effectiveness of a combination of three drugs: Epcoritamab, Zanubrutinib, and Rituximab. The study will take place at multiple centers and will involve about 24 participants.

Participants will undergo a series of tests and procedures, including blood tests, scans, and questionnaires, to monitor their health and the treatment's effects. The treatment will last approximately 24 months, with follow-up visits every 6 months for up to 10 years.

The study is supported by Genmab and BeiGene, who are providing the study drugs and funding. The U.S. Food and Drug Administration (FDA) has approved these drugs for use in people who have already received at least two prior treatments for follicular lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CD20+ follicular lymphoma (grade 1-3A) and have had at least one previous treatment that included a CD20 antibody and an alkylating agent.
  • Have measurable disease, meaning at least one tumor that can be measured by scans.
  • Meet certain criteria for starting treatment, such as having symptoms or large tumors.
  • Be in good overall health with an ECOG performance status of 0-2.
  • Be 18 years or older.
  • Have adequate blood counts and organ function.
  • Be willing to provide a tumor sample before starting treatment.
  • Agree to use effective contraception during and after the study, if applicable.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Need for ongoing immunosuppressive therapy or high-dose steroids.
  • Recent major surgery or significant injury.
  • Active infections or recent severe infections.
  • History of other cancers unless disease-free for at least 2 years.
  • Severe heart conditions or recent heart events.
  • Pregnant or breastfeeding women.
  • Previous organ or stem cell transplants.
  • History of severe autoimmune diseases.
  • Known allergies to study drugs.
  • Recent treatment with certain other cancer therapies.
  • Inability to comply with study requirements or take study medications.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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