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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami | 33136 | Miami | Florida |
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