Phase III International Study Comparing Mosunetuzumab Plus Lenalidomide Versus Anti-CD20 Antibody with Chemotherapy in Untreated FLIPI 2-5 Follicular Lymphoma

What this Trial Is About

Researchers are evaluating treatments for patients with previously untreated follicular lymphoma who have a FLIPI score of 2 to 5. This phase III, randomized, open-label trial compares the combination of mosunetuzumab and lenalidomide with anti-CD20 monoclonal antibody plus chemotherapy. The study aims to assess the efficacy and safety of these treatments in managing this type of lymphoma. Participants enter a screening period lasting up to 6 weeks before randomization and treatment. Those randomized to the experimental arm receive mosunetuzumab with step-up dosing followed by lenalidomide over an induction phase of about 11 months, then a maintenance phase lasting up to 17 months, totaling around 30 months of treatment. The control arm includes different combinations of anti-CD20 antibodies with chemotherapy drugs CHOP or bendamustine over induction phases of about 5 months, followed by maintenance for up to 22 months, also totaling about 30 months. Patients are not allowed to switch from control to experimental treatments. Throughout the study, participants undergo regular follow-up visits for up to 7 years after the last patient is randomized. Follow-up includes assessments every 3 months for the first two years, then every 6 months for three years, and yearly thereafter. Researchers monitor progression-free survival, overall survival, response rates, adverse events, and other health measures. The total study duration is expected to be around 10 years from the start of enrollment to final follow-up.

Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5