Phase 2 Study of Glofitamab and Gemcitabine and Oxaliplatin (Glofit-GemOx) Bridging to Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas
Massachusetts General Hospital
Summary
The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell lymphomas. This clinical trial also aims to investigate other efficacy parameters of the combination of Glofit-GemOx plus liso-cel and assess the safety of the combination of Glofit-GemOx bridging plus liso-cel. The main questions it aims to answer are: * How effective Glofit-GemOx bridged to liso-cel therapy is compared to liso-cel alone? * How will Glofit-GemOx bridged to liso-cel therapy affect other factors such as how long treatment effects last, how long patients survive after treatment, re-hospitalization rates, and more? * How many patients receiving Glofit-GemOx bridging to liso-cel will experience side effects of differing severities? Participants will receive an obinutuzumab intravenous infusion 3 days prior to undergoing a leukapheresis procedure. 2 days after leukapheresis, participants will receive 1-2 cycles of Glofit-GemOx therapy via intravenous infusion. After completing Glofit-GemOx therapy, participants will receive lymphodepleting chemotherapy via intravenous infusion for 3 consecutive days, 3-5 days prior to then receiving an intravenous infusion of liso-cel.
Description
This is a multi-center, phase II single-arm study to assess the efficacy and safety of glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) as bridging therapy followed by lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory large B-cell lymphomas. Participants will also receive obinutuzumab pre-treatment and undergo apheresis. The U.S. Food and Drug Administration (FDA) has approved obinutuzumab as a treatment option for relapsed/refractory large B-cell lymphomas. Obinutuzumab is a targeted cancer drug called a monoclonal antibody. Obinutuzumab works by attaching to a specifi…