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

ConditionsB-Cell Non-Hodgkin LymphomaBurkitt LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedEBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedHigh Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 RearrangementsHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedPrimary Mediastinal Large B-Cell LymphomaT-Cell/Histiocyte-Rich Large B-Cell LymphomaTransformed B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma to Diffuse Large B-Ce
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

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 EPOCH-R, including, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (400 mg/m²)

Prior systemic treatment for lymphoma. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response

Transformation from indolent lymphoma 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

Prior organ transplantation

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Cyclophosphamide

    Drug

    Given IV

  • Doxorubicin

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Epcoritamab

    Biological/Vaccine

    Given SC

  • Etoposide

    Drug

    Given IV

  • Fludeoxyglucose F-18

    Other intervention

    Given fludeoxyglucose

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Prednisone

    Drug

    Given PO

  • Rituximab

    Biological/Vaccine

    Given IV

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Treatment (Epcoritamab and EPOCH-R)Experimental treatment 14 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Using Common Terminology Criteria for Adverse Events version 5.0. Estimate safety and tolerability of combining epcoritamab with dose adjusted etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab.

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

Secondary outcomes

1

Percentage of patients that achieve a complete remission (CR) following study treatment

A simple binary proportion will be used to estimate CR.

Time frame
From the time of a subject signing consent, up until off study visit or end of treatment (Up to 18 weeks)
2

Progression free survival (PFS)

Kaplan-Meier method will be used to estimate PFS.

Time frame
Up to 5 years
3

Overall survival (OS)

Kaplan-Meier method will be used to estimate OS.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov
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