A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy
Beth Israel Deaconess Medical Center
Summary
This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment. The name of the study drug in this research study is: -Epcoritamab (a type of antibody)
Description
This is a prospective, phase 2, single arm, open label trial investigating epcoritamab in participants with follicular lymphoma (FL) who have failed to achieve a complete response after frontline therapy. Epcoritamab is a bispecific antibody, a synthetic protein that activates the immune system to target cancer cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for follicular lymphoma but it has been approved for other uses. The research study procedures include screening for eligibility, treatment study visits, questionnaires, Computerized Tomography (CT) scans,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded. * Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \>1.0 cm and Deauville ≥ 4 seen on baseline PET/CT * Stage III/IV at initial diagnosis * 1 prior line (at least 3 cycles) of systemic "upfront" or first-line therapy consisting of anti-C…
Interventions
- DrugEpcoritamab
Humanized IgG1 bispecific antibody, 5 or 60 mL vial, via subcutaneous (under the skin) injection per protocol.
Locations (3)
- StanfordStanford, California
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Icahn School of Medicine at Mount SinaiNew York, New York