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NCT04231877 · ClinicalTrials.gov record · last posted 2026-08-21

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Started2020-10-27
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-22
notable
Enrollment closed, study ongoing
Trial Details
NCT Number NCT04231877
Lead Sponsor University of Washington
Collaborators: Genentech, Inc.
Conditions Aggressive Non-Hodgkin Lymphoma, ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-Cell Lymphoma, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma +1 more
Enrollment 56 participants
Start Date 2020-10-27
Primary Completion 2026-12-01 (estimated)
Study Completion 2031-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-21