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.
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 at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab. III. To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab. IV. To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab. V. To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive rituximab intravenously (IV) on day 1 of cycle 1 and receive rituximab and hyaluronidase subcutaneously (SC) on days 8, 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles. Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and/or positron emission tomography (PET)/CT and blood sample collection on study and during follow up. ARM II: Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up. After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly for a total of 10 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Undergo blood sample collection
Undergo CT and/or PET/CT scan
Given SC
Undergo PET/CT scan
Given IV
Given SC
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
RECRUITINGMayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
RECRUITINGBanner University Medical Center - Tucson
Tucson, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
3-year milestone progression free survival (PFS)
Time frame: From date of registration to date of first observation of progressive disease, transformation to diffuse large B cell lymphoma, or death due to any cause, up to 3 years
PFS
Time frame: From date of registration to date of first observation of progressive disease, transformation to diffuse large B cell lymphoma, or death due to any cause, up to 10 years
Overall survival
Will be estimated using the method of Kaplan-Meier and compared between treatment arms using cox regression model.
Time frame: Up to 10 years
Overall response rate
Time frame: At week 40
Event free survival (EFS)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms using cox regression model.
Time frame: From date of registration to date of first occurrence of EFS event, up to 10 years
Incidence of adverse events
Will be evaluated using the Common Terminology Criteria for Adverse Events version 5 items.
Time frame: Up to end of treatment
Restricted chance of longer PFS
Time frame: Up to 10 years
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Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
RECRUITINGUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGHighlands Oncology Group - Rogers
Rogers, Arkansas, United States
RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
RECRUITINGTower Cancer Research Foundation
Beverly Hills, California, United States
RECRUITINGCity of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITING...and 241 more locations