Mosunetuzumab + Zanubrutinib/Polatuzumab Vedotin for Marginal Zone Lymphoma
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Boyu Hu
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with marginal zone lymphoma (including splenic, nodal, and extranodal types) that has come back or not improved after treatment. Participants must have measurable disease on scans and symptoms from their lymphoma. People with only stomach/intestinal or skin involvement are not eligible.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Mosunetuzumab
- Polatuzumab Vedotin
- Zanubrutinib
Trial Overview
The study compares three treatments: mosunetuzumab alone, mosunetuzumab plus zanubrutinib, and mosunetuzumab plus polatuzumab vedotin. Patients are randomly assigned to one of these groups to see which works best for relapsed or hard-to-treat marginal zone lymphoma.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles. Patients also receive polatuzumab vedotin IV, over 30-90 minutes, on day 1 of each cycle (cycles 1-6 only). Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients who achieve CR or PD discontinue treatment. Patients with PR or SD continue treatment with mosunetuzumab alone for an additional 9 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT, CT, clinically indicated bone marrow biopsy, and blood sample collection throughout the study.
Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles. Patients also receive zanubrutinib PO QD or BID on days 1-21 of each cycle. Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients who achieve CR or PD discontinue treatment. Patients with PR or SD continue treatment for an additional 9 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT, CT, clinically indicated bone marrow biopsy, and blood sample collection throughout the study.
Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients who achieve CR or PD discontinue treatment. Patients with PR or SD continue treatment for an additional 9 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT, CT, clinically indicated bone marrow biopsy, and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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