Study on Epcoritamab for Patients with Newly Diagnosed Marginal Zone Lymphoma (MZL)

Sponsor: Izidore Lossos, MD

Sponsor score: 0

ClinicalTrials ID:NCT06796998

This clinical trial is exploring whether the investigational drug Epcoritamab can be beneficial for patients who have been newly diagnosed with Marginal Zone Lymphoma (MZL).

Patient Parameters

Program Overview

The aim of this study is to find out if Epcoritamab, a new treatment being tested, can help patients with Marginal Zone Lymphoma (MZL), a type of cancer that affects the lymphatic system.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Willing to sign a consent form and follow the study protocol.
  • Diagnosed with Marginal Zone Lymphoma (MZL), including Extranodal, Nodal, and Splenic subtypes, at any stage (I-IV).
  • Have not received any previous treatment for MZL.
  • Have measurable disease, meaning the cancer can be seen and measured on scans or through other tests.
  • For those with skin, gastric, or conjunctival MZL, specific criteria apply for eligibility based on lesion size and previous treatments.
  • Willing to provide a tissue sample for study purposes, if possible.
  • Must meet certain health criteria, such as having a life expectancy of more than 3 months and adequate blood, liver, and kidney function.
  • Women and men must agree to use effective birth control during the study and for at least 90 days after the last dose.

Exclusion Criteria

  • Evidence of transformation to a more aggressive type of lymphoma.
  • History of central nervous system lymphoma or leptomeningeal disease.
  • Previous cancer treatments like chemotherapy or radiation.
  • Use of certain medications that suppress the immune system within 2 weeks before starting the study.
  • Previous stem cell transplant or CAR T-cell therapy.
  • Active graft versus host disease.
  • Recent major surgery without full recovery.
  • Other cancers within the last 3 years, except for certain non-threatening types.
  • Serious uncontrolled medical conditions.
  • Active infections requiring treatment or recent severe infections.
  • Recent live vaccinations.
  • HIV infection or history of organ transplantation.
  • Severe allergies to certain medications or components of the study drug.
  • Significant heart or lung disease.
  • Active hepatitis B or C infections.
  • History of autoimmune diseases, unless well-controlled or in remission.
  • Active COVID-19 infection or recent positive test without recovery.

Locations

FACILITYZIPCITYSTATE
University of Miami33136MiamiFlorida

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