Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma (NCT06569680) | Clinical Trial Compass
RecruitingPhase 2
Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma
United States35 participantsStarted 2024-11-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women aged 18 years or older at the time of signing informed consent.
✓. Able and willing to sign the informed consent form (ICF).
✓. Ability to comply with the trial protocol.
✓. Histologically confirmed EMZL presenting with stage I-IV disease.
✓. Previously untreated participants.
✓. 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.
✓. Participants who were previously treated with localized therapy (eg, radiation or surgery) and never received systemic therapy and present with recurrent disease are eligible upon histological confirmation of MZL.
✓. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥1 lesion that measures \>1.5 cm in the longest diameter (LDi) and ≥1.0 cm in the longest perpendicular diameter as assessed by CT or MRI, especially in extranodal sites, per response criteria for lymphomas (Cheson, et al., 2014). Imaging must be conducted within 6 weeks prior to the start of therapy.
Exclusion criteria
✕. Evidence of diffuse large B cell lymphoma (DLBCL) transformation. Participants with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.
✕. History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. Participants with Dural MZL are eligible.
✕. Patients that need immediate cytoreduction.
✕. Concurrent or previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
✕. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (\>20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1.
✕. Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Participants receiving corticosteroids must be at a dose level ≤20 mg/day within 7 days of the trial intervention administration.
✕. The use of inhaled corticosteroids is permitted
✕. The use of mineralocorticoids for management of orthostatic hypotension is permitted