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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07097363
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Epcoritamab — BIOLOGICAL
    Given SC
  • Etoposide — DRUG
    Given IV
  • Fludeoxyglucose F-18 — OTHER
    Given fludeoxyglucose
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Dec 7, 2025
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Epcoritamab and EPOCH-R)
    Patients receive rituximab IV on day 1, prednisone PO BID on days 1-5, etoposide IV and doxorubicin on days 1-4 and cyclophosphamide IV on day 5 of each cycle. Patients also receive epcoritamab SC on days 8 and 15 of cycle 1, days 1, 8 and 15 of cycles 2-4 and day 1 of cycles 5-6. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and receive fludeoxyglucose and undergo PET scan, CT scan, bone marrow biopsy and aspirate (if needed), and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: From the time of a subject signing consent, up until prior to Cycle 3 Day 1 (up to 42 days from Cycle 1 Day 1) or off study visit, whichever occurs earlier ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Mengyang Di, MD, PhD
[email protected]
206-606-2519
Mengyang Di, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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