University of Washington
This phase II trial tests how well polatuzumab vedotin, mosunetuzumab, and acalabrutinib work in treating patients with mantle cell lymphoma. 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. 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). Acalabrutinib 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 mantle cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving polatuzumab vedotin, mosunetuzumab, and acalabrutinib together may be an effective treatment option for patients with mantle cell lymphoma.
OUTLINE: INDUCTION: Patients receive polatuzumab vedotin intravenously (IV) over 30-90 minutes on day 1 of cycles 1-6, mosunetuzumab subcutaneously (SC) on days 1, 8, and 15 of cycle 1 and on day 1 of cycles 2-17, and acalabrutinib orally (PO) twice daily (BID) on days 1-21 of cycles 1-17. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve less than partial response (PR) discontinue study. Standard risk patients who achieve CR proceed to surveillance. Responding high-risk patients and responding standard risk pa…
Inclusion Criteria: * Patients ≥ 18 years of age * Ability to understand and willingness to sign a written informed consent document * Patients must have histologic confirmation of mantle cell lymphoma defined by the World Health Organization (WHO) classification and local institutional review * Participants must have measurable disease, defined as FDG-avid sites on baseline PET/CT measuring 1.5 cm for nodal lesions or 1 cm for extranodal lesions; and/or splenomegaly over 13 cm in largest dimension. Patients with marrow-only mantle cell lymphoma (MCL) are permitted but response assessment req…
Given IV
Given PO
Given SC
Undergo bone marrow biopsy
Undergo core biopsy
Undergo FDG PET/CT
Ancillary studies
Undergo surveillance
Undergo collection of blood samples
Undergo bone marrow aspiration