Study on Epcoritamab and Ibrutinib for Treating Relapsed or Hard-to-Treat Aggressive B-Cell Non-Hodgkin Lymphoma

Sponsor: Yazeed Sawalha

Sponsor score: 0

ClinicalTrials ID:NCT06536049

Provider View

This clinical trial is testing a combination of two drugs, epcoritamab and ibrutinib, to see if they are safe and effective in treating aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if using epcoritamab, a drug that helps the immune system target cancer cells, together with ibrutinib, a drug that stops cancer cells from growing, can effectively treat aggressive B-cell non-Hodgkin lymphoma that has come back or is resistant to other treatments. Epcoritamab works by bringing immune cells and cancer cells together to help the immune system attack the cancer. Ibrutinib helps by weakening the cancer cells and possibly making the immune cells stronger.

Description

The main goals of this study are to find the best dose of the drug combination and to see how safe it is for patients. Researchers will also look at how well the treatment works in shrinking the cancer and how long patients stay free of cancer after treatment.

Patients will take ibrutinib by mouth daily and receive epcoritamab through injections under the skin on specific days of each treatment cycle. The treatment cycles last 28 days, and patients can receive up to 6 cycles of ibrutinib and up to 12 cycles of epcoritamab, as long as the cancer does not get worse and side effects are manageable.

Throughout the study, patients will have regular blood tests, scans, and possibly bone marrow tests to monitor their health and the treatment's effects. After finishing the treatment, patients will have follow-up visits every few months for up to five years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a specific type of aggressive B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments.
  • Have received at least two previous treatments for lymphoma, or one if the disease is high-risk and returned within 12 months.
  • Be 18 years or older.
  • Be in good overall health, with a performance status score of 0 to 2, meaning fully active or able to do light work.
  • Have measurable disease, meaning the cancer can be seen and measured on scans.
  • Have certain blood counts and organ function within specified limits.
  • Agree to use effective birth control during the study and for 12 months after treatment.
  • Women must have a negative pregnancy test before starting the study.
  • Be able to understand and agree to sign a consent form to participate in the study.

Exclusion Criteria

  • Have had previous treatment with a similar type of drug targeting CD3 and CD20.
  • Need immediate treatment for lymphoma symptoms.
  • Have had a stem cell transplant from a donor within the last 180 days or have ongoing complications from it.
  • Be taking certain medications that affect how the study drugs work.
  • Have had major surgery within the last four weeks.
  • Have active cancer in the brain or spinal cord.
  • Have uncontrolled infections or heart problems.
  • Have severe liver disease or lung problems.
  • Have had a stroke or significant bleeding issues recently.
  • Be unable to swallow pills or have digestive issues affecting drug absorption.
  • Have a history of other serious medical or mental health conditions that could interfere with the study.
  • Be pregnant or breastfeeding.
  • Have certain viral infections like active hepatitis or HIV.

Locations

FACILITYZIPCITYSTATE
University of Minnesota/Masonic Cancer Center55455MinneapolisMinnesota
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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