This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
OUTLINE: Patients receive mosunetuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT) on study. Patients may undergo CT and/or magnetic resonance imaging (MRI) as clinically indicated and may undergo collection of oral and/or rectal swabs on study. After completion of study treatment, patients are followed up at week 13, at 6 months, and then for up to 5 years per institutional standards.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Undergo blood, oral, and/or rectal sample collection
Undergo PET/CT or CT
Undergo MRI
Given IV
Undergo PET/CT
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGOverall response (OR)
OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.
Time frame: Up to week 13
Incidence of adverse events (AE's)
All AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by type, severity, duration, and attribution.
Time frame: Up to 30 days after last dose of study treatment
Incidence of grade 3 or greater cytokine release syndrome (CRS)
CRS will be graded by the American Society for Transplantation and Cellular Therapy Consensus Grading system.
Time frame: Up to 30 days after last dose of study treatment
Incidence of Immune Effector Cell Associated Neurotoxicity syndrome
Time frame: Up to 30 days after last dose of study treatment
Progression free survival (PFS)
Kaplan-Meier methodology will be used to estimate PFS.
Time frame: At initiation of study treatment to disease progression, up to 5 years
Duration of response
Time frame: Up to 5 years
Time to next lymphoma treatment
Kaplan-Meier methodology will be used to estimate time to next lymphoma treatment.
Time frame: At initiation of study treatment to initiation of next therapy, up to 5 years
Time to cytotoxic treatment
Kaplan-Meier methodology will be used to estimate time to cytotoxic treatment.
Time frame: At initiation of study treatment to initiation of cytotoxic treatment, up to 5 years
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