Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
National Cancer Institute (NCI)
Summary
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.
Description
PRIMARY OBJECTIVES: I. To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm. II. To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab. II. To compare overall response rates…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory. * NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not required. Molecular testing is not required. * Participants must not have follicula…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT and/or PET/CT scan
- BiologicalMosunetuzumab
Given SC
- ProcedurePositron Emission Tomography
Undergo PET/CT scan
- BiologicalRituximab
Given IV
- BiologicalRituximab and Hyaluronidase Human
Given SC
Locations (264)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- Highlands Oncology Group - FayettevilleFayetteville, Arkansas
- University of Arkansas for Medical SciencesLittle Rock, Arkansas