Comparing Rituximab and Mosunetuzumab Treatments for People with Low Tumor Burden Follicular Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06337318
This study is comparing two treatments, rituximab and mosunetuzumab, to see which is more effective for people with follicular lymphoma that has a low tumor burden. Both drugs are antibodies that help the immune system target cancer cells, but it is not yet known which one works better for this type of lymphoma.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This phase III clinical trial is testing two different treatments for people with follicular lymphoma that has a low tumor burden. The study is comparing rituximab, a drug that targets a protein on cancer cells to help the immune system destroy them, with mosunetuzumab, another drug that may stop cancer cells from growing and spreading. The goal is to find out which treatment is more effective in controlling the disease.
Description
The main goal of this study is to compare how long patients with low tumor burden follicular lymphoma can live without their disease getting worse when treated with either rituximab or mosunetuzumab. Researchers will also look at overall survival rates, response rates at 40 weeks, and any side effects from the treatments.
Participants will be randomly assigned to one of two groups:
-
Group 1: Patients will receive rituximab through an IV on the first day of the first cycle, and then under the skin on days 8, 15, and 22 of the first cycle, and on the first day of the following cycles. Each cycle lasts 56 days, and treatment can continue for up to 5 cycles unless the disease progresses or side effects become too severe.
-
Group 2: Patients will receive mosunetuzumab under the skin on days 1, 8, and 15 of the first cycle, and on the first day of the following cycles. Each cycle lasts 21 days, and treatment can continue for up to 8 cycles unless the disease progresses or side effects become too severe.
Throughout the study, patients will have CT or PET/CT scans and blood tests to monitor their condition. After completing the treatment, patients will have follow-up visits every 6 months for 5 years, and then once a year for a total of 10 years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of classic follicular lymphoma (cFL) or certain uncommon types of follicular lymphoma.
- Must not have follicular lymphoma with certain aggressive features.
- Must have low-tumor burden follicular lymphoma, meaning:
- Tumor size less than 7 cm in diameter.
- No more than 3 tumor sites larger than 3 cm.
- No symptoms like fever, weight loss, or night sweats.
- No enlarged spleen causing symptoms.
- No compression of organs or fluid buildup due to lymphoma.
- Must have stage II, III, or IV follicular lymphoma, or stage I if not suitable for radiation.
- Must have recent imaging tests to assess the disease.
- Must have at least one measurable tumor.
- Must not have had previous systemic therapy for follicular lymphoma.
- Must be 18 years or older.
- Must have a good performance status (able to carry out daily activities).
- Must have recent medical history and physical exam.
- Must meet specific blood test criteria for white blood cells, hemoglobin, neutrophils, platelets, liver function, and kidney function.
- Must not have active or uncontrolled infections, diabetes, or high blood pressure.
- Must have controlled HIV, hepatitis B, or hepatitis C if applicable.
- Must not have active autoimmune disease or have had an organ transplant requiring ongoing immunosuppressive therapy.
- Must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential.
- Must be willing to participate in specimen banking for future research.
- Must understand the study and sign informed consent, or have a representative do so if unable.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.