Gottfried von Keudell, MD PhD
The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is: -Odronextamab (a type of monoclonal antibody)
This prospective, phase 2, single-arm, open label study is to evaluate the safety and effectiveness of Odronextemab in participants with previously untreated Follicular Lymphoma (FL). Odronextemab is a type of immunotherapy is a cancer treatment that uses the body's own immune system to fight cancer cells. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, Computerized Tomography (CT) scans, Positron Emission (PET) scans, echocardiograms (ECGs), bone marrow biopsies and aspirations, and tumor biopsies. The U.S. Food and Drug Admini…
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. * Lymph node biopsy obtained in the previous 6 months * Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm * Age ≥18 years * ECOG performance status \> 2 * Life expectancy of \> 2 years * Participants must meet the following organ and marrow function as defined below: * Absolute neutrophil count ≥1…
A CD20xCD3 bispecific monoclonal antibody, glass vials, via intravenous (into the vein) infusion per protocol.
Arctuva estimate
Verify or correct the compensation shown for this listing.