Phase 2 Study of Epcoritamab Combined With Dose-Adjusted EPOCH-R Chemotherapy for First-Line Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas

What this Trial Is About

Researchers are evaluating the safety, optimal dose, and effectiveness of epcoritamab combined with the chemotherapy regimen EPOCH-R for treating patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that targets both CD3 on T-cells and CD20 on B-cells, which may help stop cancer growth. This phase II trial aims to find out how well this combination works and how tolerable it is for patients with this aggressive lymphoma. Patients receive rituximab through an intravenous IV infusion on day 1, prednisone orally twice daily from days 1 to 5, etoposide and doxorubicin IV on days 1 to 4, and cyclophosphamide IV on day 5 of each 21-day cycle. Epcoritamab is given as a subcutaneous injection on days 8 and 15 of the first cycle, then on days 1, 8, and 15 of cycles 2 to 4, and on day 1 of cycles 5 and 6. This treatment schedule is repeated for up to six cycles unless the disease progresses or side effects become unacceptable. During the study, participants undergo heart function tests like MUGA scan or echocardiography at screening. They also receive PET and CT scans, blood sample collections, and bone marrow biopsies if needed throughout the treatment. After completing the treatment, patients are followed for up to five years to monitor outcomes and safety. The main outcome measured is the occurrence of side effects during the first part of the treatment, with additional results tracking remission rates and survival over five years.

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