About this trial
This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically diagnosed CD20+ marginal zone lymphoma (MZL) as per World Health Organization (WHO) criteria including splenic, nodal, and extranodal subtypes, but excluding gastrointestinal-only marginal zone lymphoma (MZL) with disease assessments that can only be evaluated through endoscopic methods and cutaneous-only MZL.
The participant has received prior CD3/CD20 bispecific antibody, then a repeat biopsy to document continued CD20+ MZL disease is required after the completion of the prior CD3/CD20 bispecific antibody therapy and prior to study registration.
The participant has splenic MZL in which a bone marrow biopsy pre-registration is required within 42 days prior to registration
Participants must have measurable disease by PET-CT (preferred), or CT as defined by extranodal lesion ≥ 1cm or nodal lesion ≥ 1.5cm.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Computed Tomography
Procedure/SurgeryUndergo CT scan
Mosunetuzumab
Biological/VaccineGiven SC
Polatuzumab Vedotin
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Survey Administration
Other interventionAncillary studies
Zanubrutinib
DrugGiven PO
Treatment groups
Trial outcomes
Primary outcomes
Complete response rate (arm 1 versus arm 2)
Defined by the Lugano Classification.
Complete response rate (arm 1 versus arm 3)
Defined by the Lugano Classification.
Secondary outcomes
Progression free survival
Will be calculated using the method of Kaplan-Meier and compared using a log-rank test.
Overall survival
Will be calculated using the method of Kaplan-Meier and compared using a log-rank test.
Overall response rate
Defined as complete responses and partial responses.
Duration of response
Will be calculated using the method of Kaplan-Meier and compared using a log-rank test.
Other outcomes
Incidence of symptomatic adverse events
Will be evaluated utilizing Patient Reported Outcomes-Common Terminology Criteria for Adverse Events.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SWOG Cancer Research Network
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: