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

Recruiting now · Phase 3

Conditions studied: Classic Follicular Lymphoma, Follicular Lymphoma With Unusual Cytological Features

In brief

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.

Key facts

Study ID: NCT06337318
Run by: National Cancer Institute (NCI)
People needed: 600
Starts: 2024-10-23
Expected to finish: 2032-03-31
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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

Where it is running

Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
Highlands Oncology Group - Fayetteville — Fayetteville, Arkansas, United States (enrolling)
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
Highlands Oncology Group - Rogers — Rogers, Arkansas, United States (enrolling)
Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
Tower Cancer Research Foundation — Beverly Hills, California, United States (enrolling)
City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
City of Hope Antelope Valley — Lancaster, California, United States (enrolling)
City of Hope at Long Beach Elm — Long Beach, California, United States (enrolling)
Tibor Rubin VA Medical Center — Long Beach, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
City of Hope South Pasadena — South Pasadena, California, United States (enrolling)
Torrance Memorial Physician Network - Cancer Care — Torrance, California, United States (enrolling)
City of Hope Upland — Upland, California, United States (enrolling)
UCHealth University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
Poudre Valley Hospital — Fort Collins, Colorado, United States (enrolling)
Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States (enrolling)
UCHealth Greeley Hospital — Greeley, Colorado, United States (enrolling)
Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.