A Phase 2 Study of Epcoritamab and Rituximab for First-line Treatment of Follicular Lymphoma
Reid Merryman, MD
Summary
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)
Description
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 researc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current or prior histologic transformation are excluded. * No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed. * Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria: * Symptomatic adenopathy * Organ function impairment due to disease involvement, including cytopenias due…
Interventions
- DrugEpcoritamab
T-cell bispecific antibody, via subcutaneous injection
- DrugRituximab
Chimeric anti-CD20 monoclonal antibody, via IV infusion
Locations (5)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of Rochester Medical CenterRochester, New York
- The Ohio State University Wexner Medical CenterColumbus, Ohio
- Medical College of WisconsinMilwaukee, Wisconsin