RecruitingPhase 2NCT06569680

Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

Phase II Trial of Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma (EMZL) (ML44933)


Sponsor

Izidore Lossos, MD

Enrollment

35 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. This study will help doctors understand if Mosunetuzumab improves outcomes in people with EMZL and if it is safe to use.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests mosunetuzumab, a bispecific antibody that redirects the immune system to attack lymphoma cells, in patients with newly diagnosed extranodal marginal zone lymphoma (EMZL) — a slow-growing type of blood cancer that starts in tissues outside lymph nodes (like the stomach, eyes, or salivary glands). **You may be eligible if:** - You are 18 or older with confirmed extranodal marginal zone lymphoma (EMZL) at any stage - You have not previously received systemic (whole-body) treatment for EMZL - You have at least one tumor that can be measured on imaging - You are able to comply with the study schedule - Special case: If you had stomach EMZL caused by H. pylori bacteria and were treated with antibiotics, you may still be eligible if lymphoma is confirmed on biopsy after antibiotic treatment **You may NOT be eligible if:** - You have already received systemic therapy for EMZL - Your lymphoma cannot be measured on imaging - You are not able to comply with study visits and procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMosunetuzumab

Mosunetuzumab will be administered via subcutaneous (SC) injection using a step-up dosing model. Participants will receive Mosunetuzumab on days 1, 8, and 15 of Cycle 1, and on day 1 of Cycles 2 through 8 as follows: * Cycle 1 Day 1: 5mg * Cycle 1 Day 8: 45mg * Cycle 1 Day 15: 45mg * Cycles 2 through 8, Day 1: 45mg


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06569680