Trial Identifiers
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Scientific Title
Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy
Commercial Sponsor
Hoffmann-La Roche
Summary
This is a randomised trial with two experimental arms. The Cycle length for treatment in this trial is: 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12. Participants in Experimental Arm A will receive Mosunetuzumab (administered intravenously in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12) in combination with Lenalidomide (administered orally once daily on Days 1-21 of Cycles 2-12). Participants in Experimental Arm B will receive Rituximab (administered intravenously on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11) in combination with Lenalidomide (administered orally once daily on Days 1-21 of Cycles 1-12). Tociluzumab will be administered as needed to manage cytokine release syndrome (CRS) events.