Study on Epcoritamab with EPOCH-R for Treating Aggressive B-Cell Non-Hodgkin Lymphoma

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT07097363

Provider View

This clinical trial is testing a new treatment that combines the drug epcoritamab with a standard chemotherapy regimen called EPOCH-R to see if it is safe and effective for patients with aggressive B-cell non-Hodgkin lymphoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, best dose, and effectiveness of a new drug called epcoritamab when used with a chemotherapy regimen known as EPOCH-R. Epcoritamab is a special type of antibody that can attach to two different targets on cancer cells, potentially helping the immune system to attack and kill these cells. The EPOCH-R regimen includes several chemotherapy drugs that work together to stop cancer cells from growing and dividing. This study aims to find out if adding epcoritamab to EPOCH-R can improve treatment outcomes for patients with aggressive B-cell non-Hodgkin lymphoma.

Description

In this study, patients will receive a combination of drugs as part of their treatment. They will get rituximab through an IV on the first day of each cycle, and take prednisone by mouth twice a day for the first five days. Etoposide and doxorubicin will be given through an IV on days 1 to 4, and cyclophosphamide on day 5. Epcoritamab will be given as an injection under the skin on specific days throughout the treatment cycles. Each cycle lasts 21 days, and patients will go through six cycles unless the disease progresses or side effects become too severe. Throughout the study, patients will have various tests, including heart scans, PET and CT scans, and blood tests, to monitor their health and the treatment's effectiveness. After completing the treatment, patients will have follow-up visits for up to five years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have not been treated for aggressive large-B cell lymphoma before, and the disease has certain features that suggest a standard treatment might not work well.
  • Be planned to receive a full course of six cycles of chemoimmunotherapy as part of standard care.
  • Be 18 years or older.
  • Have measurable disease, with at least one tumor that can be measured by scans.
  • Be in good overall health with a performance status score of 0 to 2.
  • Have a heart function of at least 50% as measured by specific heart tests.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for 12 months after the last treatment.
  • Men must agree to use condoms or abstain from intercourse and refrain from donating sperm during the study and for six months after.

Exclusion Criteria

  • Have allergies or severe reactions to any of the study drugs or similar medications.
  • Have received prior treatment for lymphoma, except for certain cases where one cycle of treatment was given for symptom control.
  • Have had an organ transplant.
  • Have certain nerve disorders or severe nerve damage.
  • Have other serious health conditions that could interfere with the study.
  • Have had major surgery within four weeks before starting the study.
  • Have active infections that require treatment.
  • Have certain viral infections like hepatitis B or C, or uncontrolled HIV.
  • Be pregnant or breastfeeding, or planning to become pregnant during the study.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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