Study on Epcoritamab and Rituximab for First-time Treatment of Follicular Lymphoma

Sponsor: Reid Merryman, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05783609

Provider View

This clinical trial is testing the combination of two drugs, rituximab and epcoritamab, to see how well they work and how safe they are for patients with Follicular Lymphoma who have not yet received any treatment for their condition.

Patient Parameters

Program Overview

The study aims to find out if using rituximab and epcoritamab together is effective and safe for treating patients with Follicular Lymphoma (FL) who have not had any previous treatments. Rituximab is already approved for treating FL, while epcoritamab is still being studied. Participants will undergo various procedures, including blood tests and scans, and will receive treatment for about 9-10 months, with follow-up for up to 10 years. Around 35 people are expected to participate in this study, which is supported by Genmab and AbbVie.

Description

This study is open to patients with untreated Follicular Lymphoma (FL) and will test the effectiveness and safety of combining two drugs: epcoritamab and rituximab. Epcoritamab helps T cells target and kill lymphoma cells, while rituximab activates the immune system to attack the cancer. Although rituximab is approved for FL, epcoritamab is not yet approved for any disease. Participants will be screened for eligibility and will undergo various tests, including blood tests, bone marrow biopsies, and imaging scans. The treatment will last approximately 9-10 months, and participants will be monitored for up to 10 years. The study is supported by Genmab and AbbVie, who are providing the drug epcoritamab and funding for the research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CD20+ Follicular Lymphoma (grade 1-3A) without any previous transformation.
  • No prior systemic therapy for FL, but previous radiation or short-term steroid use is allowed.
  • Must meet at least one criterion for starting treatment, such as:
    • Symptoms like swollen lymph nodes or organ issues due to the disease.
    • Significant weight loss, fever, or night sweats.
    • Large tumor masses or multiple affected lymph nodes.
    • Enlarged spleen or significant fluid buildup.
    • Rapid disease progression or bone involvement.
  • Not in need of urgent chemotherapy.
  • ECOG performance status of 0-2, meaning fully active or with some limitations.
  • Aged 18 years or older.
  • Adequate blood and organ function based on specific tests.
  • Willing to provide a tumor sample for analysis.
  • Agree to use effective contraception during and after the study for a specified period.

Exclusion Criteria

  • Need for ongoing systemic immunosuppressive therapy.
  • Bulky lymph nodes that could compress the airway.
  • Stage I Follicular Lymphoma or candidates for curative radiation therapy.
  • Recent major surgery or significant injury.
  • Active hepatitis B or C infections, or HIV.
  • Active infections or significant infections recently.
  • History of another cancer unless disease-free for at least 2 years.
  • Recent live vaccine immunization.
  • Severe or uncontrolled medical conditions.
  • Recent heart issues or severe heart failure.
  • Inability to comply with study requirements.
  • Pregnant or breastfeeding women.
  • Previous organ or stem cell transplants.
  • History of autoimmune diseases or severe allergic reactions to similar treatments.
  • Recent treatment with CAR-T therapy or investigational drugs.
  • Active central nervous system lymphoma or severe neuropathy.

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