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

Summary

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.

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
• Gray-Zone Lymphoma

Interventions

DRUG

Polatuzumab Vedotin

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Prednisone

Given PO

DRUG

Etoposide

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Glofitamab

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET scan

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Ryan Lynch · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-27

Primary Completion

2026-12-01

Completion

2031-12-01

FDA Drug

Yes

Countries

• United States

Study Locations