Follicular Lymphoma Clinical Trial
Official title:
A Phase 2 Study of Epcoritamab and Rituximab for First-line Treatment of Follicular Lymphoma
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: - Rituximab (a type of monoclonal antibody therapy) - Epcoritamab (a T-cell bispecific antibody)
This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab and rituximab for patients with untreated follicular lymphoma (FL). Epcoritamab brings T cells and follicular lymphoma cells close together and activates the T cells to kill the lymphoma cells. Rituximab activates the immune system to kill the lymphoma cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved rituximab as a treatment option for follicular lymphoma (FL). The research study procedures include screening for eligibility, study treatment with evaluations, blood tests, bone marrow biopsies, and Computerized Tomography (CT) scans and Positron Emission Tomography (PET) scans. Participants will receive study treatment for approximately 9-10 months and will be followed for up to 10 years. It is expected that about 35 people will take part in this research study. Genmab and AbbVie are supporting this research study by providing one of the study drugs, Epcoritamab. Genmab is providing funding for the study. ;
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