About this trial
This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab 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). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.
Eligibility criteria
Qualifiers
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
High grade B-cell lymphoma, not otherwise specified (NOS)
Diffuse large B-cell lymphoma (DLBCL) NOS
Primary mediastinal B-cell lymphoma
Disqualifiers
Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response.
Richter's transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma is not allowed. Transformation from follicular or other indolent lymphomas is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion 1
Diagnosis of Burkitt lymphoma
Trial design
Treatments tested in this trial
- Polatuzumab Vedotin
- Rituximab
- Prednisone
- Etoposide
- Doxorubicin
- Cyclophosphamide
- Glofitamab
- Multigated Acquisition Scan
- Echocardiography Test
- FDG-Positron Emission Tomography
- Computed Tomography
- Bone Marrow Biopsy
- Biospecimen Collection
- Bone Marrow Aspiration
Treatment groups
Sponsors and collaborators
University of Washington
Lead sponsor
Genentech, Inc.
Collaborator