Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma

Summary

This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.

Conditions

• B-Cell Non-Hodgkin Lymphoma
• Burkitt 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
• Transformed B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma to Diffuse Large B-Ce

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

BIOLOGICAL

Epcoritamab

Given SC

DRUG

Etoposide

Given IV

OTHER

Fludeoxyglucose F-18

Given fludeoxyglucose

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Positron Emission Tomography

Undergo PET scan

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Mengyang Di, MD, PhD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-07

Primary Completion

2030-05-31

Completion

2030-05-31

FDA Drug

Yes

Countries

• United States

Study Locations