Study on the Safety and Effectiveness of Epcoritamab with Chemotherapy for Relapsed Large B-cell Lymphoma

Sponsor: Dipenkumar Modi

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05852717

Provider View

This clinical trial is testing a combination of the drug epcoritamab with chemotherapy drugs gemcitabine, dexamethasone, and cisplatin (GDP) to see if it is safe and effective for patients with large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

In this study, patients with relapsed large cell lymphoma will receive three cycles of a combination treatment that includes the chemotherapy drugs GDP and the drug epcoritamab. Each treatment cycle lasts 21 days. After completing the three cycles, patients will have imaging tests to assess their disease. Depending on the results, patients may proceed to stem cell transplantation, CAR T-cell therapy, or continue with epcoritamab alone. The decision will be made by the study doctor based on each patient's situation.

Description

Patients in this study will receive a combination of chemotherapy drugs and epcoritamab over three cycles, each lasting 21 days. The chemotherapy includes gemcitabine, cisplatin, and dexamethasone, while epcoritamab is given as an injection under the skin. After the third cycle, patients will have imaging tests to check the status of their lymphoma. Depending on the results, patients may move on to other treatments like stem cell transplantation or CAR T-cell therapy, or they may continue with epcoritamab alone if they are not eligible for the other treatments. The study aims to find out if this combination treatment is safe and can help control the disease.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of relapsed large B-cell lymphoma.
  • Have measurable disease based on imaging tests.
  • Have received at least one prior treatment for large cell lymphoma.
  • Be eligible for stem cell transplantation or CAR T-cell therapy.
  • Have adequate organ function and a life expectancy of at least 6 months.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • Previous treatment with the same drugs used in this study.
  • Active central nervous system involvement by lymphoma.
  • Allergic reactions to any of the study drugs.
  • Unresolved side effects from previous cancer treatments.
  • Recent major surgery or other cancer treatments.
  • History of other cancers, except certain non-threatening types.
  • Active infections requiring treatment.
  • Autoimmune diseases requiring long-term immunosuppressive therapy.
  • Active HIV infection with detectable viral load.
  • Active hepatitis B or C infections.
  • Pregnant or breastfeeding women.
  • Any serious medical condition that could affect participation in the study.

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