Clinical Trial Summary (S2308)
Comparing Rituximab and Mosunetuzumab Drug Treatments for People Who Have Follicular Lymphoma with Low Tumor Burden
What is the purpose of this clinical trial?
This trial tests treatment for follicular lymphoma (FL) that grows slowly and is not causing many problems in the body. This type of lymphoma is called low tumor burden FL.
Usually, patients who get treatment for low tumor burden FL will receive a drug called rituximab. This trial looks at using a new drug called mosunetuzumab.
Rituximab and mosunetuzumab are both immunotherapy drugs. They help the body fight off cancer cells by targeting certain proteins in blood cells.
- Rituximab targets a protein called CD20.
- Mosunetuzumab targets CD20 and CD3 proteins.
The purpose of this study is to learn which drug, rituximab or mosunetuzumab, is better to use in early treatment for low tumor burden FL.
This trial is set up to find out:
- Which drug keeps low tumor burden FL in remission (having no signs and symptoms of cancer) for a longer time
- Which drug helps people with low tumor burden FL live longer
- Which drug causes fewer and less severe side effects
Why is this trial important?
Mosunetuzumab has been approved by the Food and Drug Administration (FDA) for treating FL that came back or didn’t respond to initial treatment. Based on previous research, the study doctors believe low tumor burden FL will respond very well to early treatment with this drug. This trial is a way to see if early treatment with mosunetuzumab can improve treatment options for patients with low tumor burden FL.
Who can be in this trial?
This trial is for adults, age 18 or older, with low tumor burden follicular lymphoma (FL).
This trial is not for people who:
- Already received drug treatment for follicular lymphoma (you can still join the trial if you had radiation treatment)
- Have follicular large B-cell lymphoma
- Have diabetes or high blood pressure that is not well managed
- Are pregnant
Talk with your doctor to learn more about who can join this study.
What treatments will I get?
A computer will randomly assign you to one of 2 study groups.
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Your doctor will not have control over which group you will be assigned to. This helps make sure the study results are fair and reliable.
How long will I be in the trial?
You will be in the study for 10 years. After treatment in the study (about 10 months if you receive rituximab and about 6 months if you receive mosunetuzumab), you will have follow-up visits to monitor your health.
Are there costs? Will I get paid?
The study drugs rituximab and mosunetuzumab are provided free in this study. Ask your health care provider and insurance provider about what costs will and won’t be covered in this study. You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT06337318
- For a list of trial locations, visit swog.org/NCI-S2308
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S2308
NCT Number
NCT06337318
Full Trial Title
Protocol S2308 Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Trial Sponsors
SWOG Cancer Research Network
Publication Date