Actively Recruiting
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma
Led by University of Washington · Updated on 2026-04-23
18
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated aggressive large B-cell lymphoma with features predicting sub-optimal response to R-CHOP and planned to receive full 6 cycles of DA-EPOCH-R
- Up to 1 prior cycle of chemoimmunotherapy allowed
- Eligible lymphoma types include high grade B-cell lymphoma with MYC and BCL2/BCL6 translocations, DLBCL NOS, primary mediastinal B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, EBV+ DLBCL NOS, Burkitt lymphoma, and unclassifiable B-cell lymphoma with features between DLBCL and Hodgkin lymphoma
- Willing and able to provide written informed consent
- Age 18 years or older at consent
- Measurable disease with at least one nodal site ≥1.5 cm or extranodal site ≥1.0 cm on CT or FDG-PET
- ECOG performance status 0-2 at enrollment
- Left ventricular ejection fraction ≥50% on MUGA or echocardiogram
- Absolute neutrophil count ≥1,000/μL except in marrow infiltration cases
- Platelets ≥75,000/μL except in marrow infiltration or hypersplenism
- Hemoglobin ≥8 g/dL except in marrow infiltration cases without recent transfusion
- Creatinine clearance or GFR ≥45 mL/min
- Serum total bilirubin ≤1.5 x ULN (or ≤3.0 x ULN with Gilbert disease) or direct bilirubin ≤ULN if total bilirubin >1.5 x ULN
- AST and ALT ≤2.5 x ULN or ≤5 x ULN with liver involvement
- INR ≤1.5 x ULN unless on anticoagulants within therapeutic range
- For women of childbearing potential: agreement to abstain or use effective contraception during treatment and for 12 months after last dose, and negative pregnancy test at screening
- For men: agreement to abstain or use condoms during treatment and for 6 months after last dose, and refrain from sperm donation
You will not qualify if you...
- Allergy or contraindication to any EPOCH-R components or monoclonal antibodies
- Prior systemic treatment for lymphoma (except allowed pre-study steroid or 1 cycle chemoimmunotherapy for symptom control)
- Prior organ transplantation
- Grade >1 peripheral neuropathy or Charcot-Marie-Tooth disease
- History of other malignancies affecting study compliance unless treated and in remission as specified
- Significant uncontrolled cardiovascular or pulmonary disease
- Recent major surgery within 4 weeks prior to cycle 1
- Abnormal ECG considered clinically significant by investigator
- Active infection requiring systemic treatment, including SARS-CoV-2 unless negative tests and recovery criteria met
- Positive hepatitis B surface antigen or active hepatitis C infection
- Uncontrolled HIV infection
- History of progressive multifocal leukoencephalopathy
- Known active central nervous system lymphoma
- Need for mid-cycle high-dose methotrexate for CNS prophylaxis
- Pregnancy, lactation, or intention to become pregnant during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mengyang Di, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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