Clinical Trials | S2308: Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have low tumor burden follicular lymphoma. The purpose of this study is to compare the usual treatment (rituximab) to using the study drug mosunetuzumab. This study will help the study doctors find out if the study drug is different, the same, or better than the usual treatment. This study has two groups. You will be told which group you are in. You will be put into a group by chance. A computer will assign you to one of the study groups. You or your doctor will not choose which study group you are in. Group 1: If you are in this group, you will get the usual drug (rituximab) used to treat this type of cancer. You will get rituximab 2 ways: through a vein in your arm (IV) and as an injection under the skin. On Day 1 of cycle 1, you will get the drug as an IV. On Days 8, 15, and 22 of Cycle 1, you will get the drug as an injection under the skin. For cycle 2-5, you will get rituximab on Day 1 of each cycle as an injection under the skin. Rituximab treatment may last up to about 10 months. The drug is given for 5 cycles. One cycle is 56 days. Group 2: If you are in this group, you will get a study drug (mosunetuzumab) as an injection under the skin. In Cycle 1, you will get this drug on Days 1, 8, and 15. For cycles 2-8, you will get mosunetuzumab only on day 1 of each cycle. Mosunetuzumab treatment may last up to about 6 months. The drug is given for 8 cycles. One cycle is 21 days. Response to treatment in either group will be evaluated with PET/CT (“PET Scan”) at end of treatment, twice a year for up to 5 years, and then annually after 5 years. You are expected to receive study treatment for up to 10 months. After study treatment, you will be followed for up to 10 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/NCT06337318 [email protected]