A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab Versus Rituximab Combined With Chemotherapy in Adults With Previously Untreated Follicular Lymphoma

What this Trial Is About

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The study aims to assess the safety, tolerability, and effectiveness of odronextamab compared to rituximab combined with chemotherapy, which is the current standard treatment. Additional questions include the study drugs side effects, blood levels, antibody responses, and impact on quality of life and daily activities. The study has two parts Part 1 is a non-randomized safety phase where all participants receive odronextamab alone. Part 2 is randomized and compares two groups one receiving odronextamab followed by maintenance treatment, and the other receiving rituximab with chemotherapy followed by rituximab maintenance. Chemotherapy types include CHOP, CVP, or bendamustine regimens, all given according to protocol. Participants will undergo regular assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor drug levels and antibodies, and questionnaires to evaluate quality of life. Researchers will track safety through dose-limiting toxicities and treatment-emergent adverse events for up to two years, and measure treatment response and survival outcomes for up to five years. Overall participation may last several years to monitor long-term effects and disease progression.

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma