Actively Recruiting
Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma
Led by Izidore Lossos, MD · Updated on 2025-11-03
35
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
Sponsors
I
Izidore Lossos, MD
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Able and willing to provide informed consent
- Able to follow the trial protocol
- Histologically confirmed EMZL with stage I-IV disease
- No previous cancer treatment for lymphoma
- Participants with H. pylori-positive gastric EMZL treated with antibiotics and confirmed MZL
- Participants previously treated with localized therapy but no systemic therapy and confirmed recurrent disease
- Measurable lymphadenopathy or extranodal lymphoma lesions as defined by CT or MRI or specific skin, gastric, or conjunctival lesion criteria
- Willing to provide tissue biopsy for diagnosis confirmation
- Must meet at least one treatment initiation criterion including threatened organ function, multiple nodal sites involvement, tumor size, B symptoms, risk of organ compromise, splenomegaly, leukopenia, leukemia, transfusion needs, or multiple extranodal sites involvement
- Life expectancy greater than 3 months
- ECOG performance status of 0 to 2
- Adequate blood, liver, and kidney function within 6 weeks before therapy
- Willingness to avoid pregnancy during the trial and for 90 days after last dose
You will not qualify if you...
- Evidence of transformed lymphoma to diffuse large B cell lymphoma
- History of central nervous system lymphoma or leptomeningeal disease (except Dural MZL)
- Need for immediate cytoreduction
- Previous or current anticancer therapy including chemotherapy, radiation, immunotherapy, or investigational treatments
- Use of systemic immunosuppressive medications above allowed doses within 2 weeks before treatment
- Prior allogeneic or autologous stem cell transplant or CAR T-cell therapy
- Active graft versus host disease
- Incomplete recovery from major surgery
- Another cancer diagnosis within 3 years except certain noninvasive or cured cancers
- Significant uncontrolled medical conditions including renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric diseases
- Active or recent serious infections requiring systemic treatment
- Recent live vaccine exposure or planned live vaccines during the study
- Known HIV infection
- History of solid organ transplant
- Severe allergic reactions to monoclonal antibodies
- Known sensitivity to components of study drugs
- Significant cardiovascular or pulmonary disease
- Known or suspected chronic active EBV infection
- History of certain immune or blood disorders
- Active hepatitis B or C infection unless viral tests are negative
- History of autoimmune diseases except certain well-controlled or stable conditions
- Positive COVID-19 test within 7 days prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
I
Izidore Lossos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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