Phase II Trial of Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma (EMZL) (ML44933)
Izidore Lossos, MD
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and women aged 18 years or older at the time of signing informed consent. 2. Able and willing to sign the informed consent form (ICF). 3. Ability to comply with the trial protocol. 4. Histologically confirmed EMZL presenting with stage I-IV disease. 5. Previously untreated participants. 1. Participants with H. pylori-positive gastric EMZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, participant has histologically confirmed MZL. 2. Participants who were previously treated with lo…
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
Location
- University of MiamiMiami, Florida