Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B)
• Participants must have low-tumor burden follicular lymphoma defined as:
  • Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
  • Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm.
  • Absence of B symptoms which may include unexplained fever, drenching sweats, unintentional weight loss (more than 10% of body weight)
  • No symptomatic splenomegaly
  • No compression syndrome (ureteral, orbital, gastrointestinal)
  • No pleural or peritoneal serous effusion related to follicular lymphoma Participants must have Ann Arbor stage II, III, or IV follicular lymphoma. Participants with stage I disease may be included if they do not wish to undergo radiation or are not candidates for radiation
• Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach
• Participants must have staging imaging performed within 49 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the chest, abdomen, and pelvis, along with a bone marrow biopsy, are acceptable. If CT scans are used for staging at baseline, a CT scan of the neck is recommended. All measurable dominant lesions must be assessed within 49 days prior to registration. Tests to assess non-measurable disease must be performed within 49 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.
  • NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast
• Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter > 1.5 cm)
• Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed
• Participant must be ≥ 18 years of age at the time of registration
• Participant must have Zubrod performance status of 0-2
• Participant must have a complete medical history and physical exam within 28 days prior to registration
• Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
• Hemoglobin > 9.0 g/dL (within 28 days prior to registration)
• Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
• Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
• Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)
• Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been collected and processed within 28 days prior to registration
• Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators
• Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators
• Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators

+ 15 more criteria — see the full checklist in the app.

Where this trial is running

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
• Banner University Medical Center - Tucson, Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
• Highlands Oncology Group - Fayetteville, Fayetteville, Arkansas, United States
• University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
• Highlands Oncology Group - Rogers, Rogers, Arkansas, United States
• Highlands Oncology Group, Springdale, Arkansas, United States
• Tower Cancer Research Foundation, Beverly Hills, California, United States
• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
• City of Hope at Irvine Lennar, Irvine, California, United States

+ 258 more sites.