Study on Mosunetuzumab for Patients with Newly Diagnosed Extranodal Marginal Zone Lymphoma
Sponsor: Izidore Lossos, MD
ClinicalTrials ID:NCT06569680
This clinical trial is testing a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL) who have not yet received any treatment. The study aims to determine if Mosunetuzumab is safe and effective for patients with stage I-IV EMZL.
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Program Overview
The purpose of this study is to evaluate a new medication, Mosunetuzumab, to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study includes individuals who have not yet received any treatment for their cancer and whose cancer is in stages I-IV. The study will help doctors understand if Mosunetuzumab improves outcomes for people with EMZL and if it is safe to use.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older.
- Able and willing to sign a consent form and follow the study protocol.
- Diagnosed with EMZL in stages I-IV.
- Have not received any prior treatment for EMZL.
- Participants with H. pylori-positive gastric EMZL who have been treated with antibiotics may be eligible if the lymphoma is confirmed after treatment.
- Participants previously treated with localized therapy (like radiation or surgery) but not systemic therapy, and have recurrent disease, are eligible if confirmed as MZL.
- Must have measurable disease by scans or specific criteria for skin, gastric, or conjunctival EMZL.
- Willing to provide a tissue biopsy or have a recent biopsy available.
- Must meet certain criteria for starting treatment, such as organ function risk, multiple large lymph nodes, large tumor mass, specific symptoms, or blood cell issues.
- Life expectancy of more than 3 months.
- Good overall health with a performance status score of 0 to 2.
- Adequate blood, liver, and kidney function based on specific tests.
- Willing to avoid pregnancy during the study and for at least 90 days after the last dose.
Exclusion Criteria
- Evidence of transformation to a more aggressive lymphoma like DLBCL.
- History of central nervous system lymphoma or leptomeningeal disease.
- Need for immediate reduction of tumor size.
- Previous or concurrent cancer treatments.
- Use of certain immunosuppressive medications recently.
- Previous stem cell transplant or CAR-T therapy.
- Active graft versus host disease.
- Not fully recovered from major surgery.
- Other cancers within the last 3 years, except certain non-threatening types.
- Uncontrolled medical conditions or active infections.
- Recent live vaccine or need for one during the study.
- HIV infection or history of organ transplantation.
- Severe allergic reactions to certain medications.
- Significant heart or lung disease.
- Active hepatitis B or C infection.
- History of autoimmune diseases, unless well-controlled or specific conditions.
- Recent positive COVID-19 test.
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