Clinical Trials | A Phase III, Open-Label, Multicenter, Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator’s Choice in Patients with Relapsed/Refractory Mantle Cell Lymphoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have Mantle Cell Lymphoma (MCL) that has spread and who have not responded to treatment. The purpose of this study is to compare the effects, good or bad, of glofitamab (experimental arm) versus bendamustine plus rituximab (BR; control arm) or rituximab plus lenalidomide (R-Len; control arm) in subjects with R/R MCL. If you are randomized to the control arm, the study doctor will discuss the two treatment options with you. If you are eligible for participation in the study, you will be placed in one of the two following study treatment groups: • Glofitamab (experimental) arm: The study treatment cycles are 21 days. You will receive glofitamab via an IV in your arm. During cycle 1, you will receive glofitamab in increasing doses on day 1, 8, and 15. During the rest of the cycles, you will receive glofitamab on day 1. You will receive up to 12 cycles of glofitamab. • BR or R-Len (control) arm: You will receive either bendamustine plus rituximab as an IV (intravenous – through a vein) infusion or rituximab as an IV infusion and lenalidomide as an oral pill. In this arm, all cycles are 28 days. You will receive rituximab on day 1 of each cycle (until your cancer worsens when combined with lenalidomide and up to 6 study treatment cycles when combined with bendamustine). Lenalidomide is an oral pill and will be given daily on days 1-21 of each cycle. Bendamustine will be give via infusion and will be administered on Day 1 and Day 2 for up to 6 cycles. Your group will be decided by chance (like tossing a coin). You will have an equal chance of being placed in either the control group or the experimental group. You are expected to be in this research study for approximately 2 years. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT06084936 [email protected]