Phase III Trial Comparing Glofitamab Alone to Investigators Choice Treatments in Adults with Relapsed or Refractory Mantle Cell Lymphoma

What this Trial Is About

Researchers are evaluating the effectiveness of glofitamab alone compared to an investigators choice of treatments for adults with relapsed or refractory mantle cell lymphoma MCL. This phase III trial focuses on patients whose lymphoma has returned or not responded after previous treatments, including those who have received BTK inhibitors. The study aims to determine which treatment better controls the disease and improves patient outcomes. Participants in the glofitamab group will first receive two intravenous doses of obinutuzumab before starting glofitamab infusions every 21 days for up to 12 cycles. Those in the comparison group will receive either bendamustine plus rituximab for up to six 28-day cycles or rituximab combined with daily oral lenalidomide for 28-day cycles until their disease progresses. Tocilizumab may be given intravenously as needed to manage side effects like cytokine release syndrome. Throughout the study, participants will undergo regular assessments including scans to measure tumor size, blood tests, and quality of life questionnaires. The main measure is progression-free survival up to about 24 months, with additional evaluations of response rates, overall survival, symptom changes, and drug levels. Safety monitoring and long-term follow-up will occur during this period to track treatment effects and patient well-being.

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma