Study on Epcoritamab and Tazemetostat for Treating Relapsed or Hard-to-Treat Follicular Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06575686

Provider View

This clinical trial is exploring the safety and effectiveness of combining two drugs, epcoritamab and tazemetostat, to treat follicular lymphoma that has either returned after treatment or hasn't responded to previous therapies.

Patient Parameters

Program Overview

This study is testing a new treatment for patients with follicular lymphoma, a type of blood cancer, that has come back or hasn't responded to other treatments. The treatment combines two drugs: epcoritamab, which helps the immune system attack cancer cells, and tazemetostat, which blocks certain enzymes that cancer cells need to grow. The goal is to see if this combination is safe and effective in shrinking the cancer.

Description

The main goals of this study are to see if the combination of epcoritamab and tazemetostat is safe and can effectively reduce cancer in patients with relapsed or hard-to-treat follicular lymphoma. Researchers will also look at how long the treatment works and how it affects patients' overall survival.

Patients will take tazemetostat pills twice a day and receive epcoritamab injections under the skin on specific days of each treatment cycle. Each cycle lasts 28 days, and patients can receive up to 13 cycles if the treatment is working and they are not experiencing severe side effects. Throughout the study, patients will have regular blood tests, scans, and possibly bone marrow biopsies to monitor their response to the treatment.

After finishing the treatment, patients will have follow-up visits at 30 and 60 days, and then periodically for up to two years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of follicular lymphoma, grades 1-3A.
  • The lymphoma must have returned after treatment or not responded to previous treatments.
  • Have at least one tumor that can be measured by scans.
  • Be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified time after.
  • Men must agree to use condoms during the study and for a specified time after.
  • Agree to provide a tumor sample for research purposes.
  • Be willing to follow all study procedures and attend follow-up appointments.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have received certain treatments like bispecific antibodies or tazemetostat before.
  • Have had a stem cell transplant recently or have complications from a previous transplant.
  • Have had recent chemotherapy, radiation, or major surgery.
  • Have active cancer in the central nervous system.
  • Have significant heart disease or uncontrolled medical conditions.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have a history of other specific blood cancers or active malignancies that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Have any condition that would make it unsafe to participate in the study or make it difficult to follow the study procedures.

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