🔎 Trials Near Me

Home › NCT06337318

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

RecruitingPhase 3

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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 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
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated. Participants with a positive total hepatitis (Hep) B core antibody and negative hepatitis B virus surface antigen (HBsAg) at screening are at high risk for reactivation and should receive prophylactic antivirals (e.g., entecavir) before and throughout the treatment
* Participants must not have autoimmune disease requiring systemic immunosuppressive therapy
* Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated
* Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required
* Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML)
* Participants must not have received allogeneic stem cell transplantation
* Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Participant must not have significant cardiovascular disease such as class III or IV cardiac disease, myocardial infarction within 6 months prior to registration. Participants with unstable arrhythmias, or unstable angina, should be excluded
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants registered by participating United States (U.S.) sites must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

About the study

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.

What is being tested

Sponsor: National Cancer Institute (NCI) · Participants: 600 · Started: Oct 23, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06337318

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Cancer Center, Birmingham
ArizonaMayo Clinic Hospital in Arizona, Phoenix
Banner University Medical Center - Tucson, Tucson
University of Arizona Cancer Center-North Campus, Tucson
ArkansasHighlands Oncology Group - Fayetteville, Fayetteville
University of Arkansas for Medical Sciences, Little Rock
Highlands Oncology Group - Rogers, Rogers
Highlands Oncology Group, Springdale
CaliforniaTower Cancer Research Foundation, Beverly Hills
City of Hope Comprehensive Cancer Center, Duarte
City of Hope at Irvine Lennar, Irvine
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
City of Hope Antelope Valley, Lancaster
City of Hope at Long Beach Elm, Long Beach
Tibor Rubin VA Medical Center, Long Beach
Cedars-Sinai Medical Center, Los Angeles
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange
City of Hope South Pasadena, South Pasadena
Torrance Memorial Physician Network - Cancer Care, Torrance
City of Hope Upland, Upland
UCI Health - Yorba Linda, Yorba Linda
ColoradoUCHealth University of Colorado Hospital, Aurora
Cancer Care and Hematology-Fort Collins, Fort Collins
Poudre Valley Hospital, Fort Collins
UCHealth Greeley Hospital, Greeley
Medical Center of the Rockies, Loveland
DelawareHelen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
District of ColumbiaMedStar Georgetown University Hospital, Washington D.C.
Sibley Memorial Hospital, Washington D.C.
FloridaUM Sylvester Comprehensive Cancer Center at Aventura, Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Springs, Coral Springs
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral, Doral
UM Sylvester Comprehensive Cancer Center at Hollywood, Hollywood
Mayo Clinic in Florida, Jacksonville
UM Sylvester Comprehensive Cancer Center at Kendall, Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
Mount Sinai Medical Center, Miami Beach
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia, North Miami
Memorial Hospital West, Pembroke Pines
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation
Moffitt Cancer Center at SouthShore, Ruskin
Moffitt Cancer Center, Tampa
Moffitt Cancer Center - McKinley Campus, Tampa
Moffitt Cancer Center-International Plaza, Tampa
Moffitt Cancer Center at Wesley Chapel, Wesley Chapel
GeorgiaEmory Saint Joseph's Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
Augusta University Medical Center, Augusta
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
IllinoisSwedish Covenant Hospital, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
Carle at The Riverfront, Danville
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Carle Physician Group-Effingham, Effingham
Crossroads Cancer Center, Effingham
Elmhurst Memorial Hospital, Elmhurst
NorthShore University HealthSystem-Evanston Hospital, Evanston
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
Carle Physician Group-Mattoon/Charleston, Mattoon
Edward Hospital/Cancer Center, Naperville
UC Comprehensive Cancer Center at Silver Cross, New Lenox
Cancer Care Center of O'Fallon, O'Fallon
University of Chicago Medicine-Orland Park, Orland Park
Edward Hospital/Cancer Center?Plainfield, Plainfield
Memorial Hospital East, Shiloh
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Carle Cancer Center, Urbana
IndianaNorthwest Cancer Center - Crown Point, Crown Point
UChicago Medicine Northwest Indiana, Crown Point
Northwest Oncology LLC, Dyer
Northwest Cancer Center - Hobart, Hobart
Saint Mary Medical Center, Hobart
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis
Saint Catherine Hospital, Indianapolis
The Community Hospital, Munster
Women's Diagnostic Center - Munster, Munster
Northwest Cancer Center - Valparaiso, Valparaiso
IowaMary Greeley Medical Center, Ames
McFarland Clinic - Ames, Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny
University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf
Mercy Hospital, Cedar Rapids
Oncology Associates at Mercy Medical Center, Cedar Rapids
UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive
Iowa Methodist Medical Center, Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines
McFarland Clinic - Trinity Cancer Center, Fort Dodge
University of Iowa/Holden Comprehensive Cancer Center, Iowa City
McFarland Clinic - Marshalltown, Marshalltown
UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee
KansasHaysMed, Hays
University of Kansas Cancer Center, Kansas City
Lawrence Memorial Hospital, Lawrence
The University of Kansas Cancer Center - Olathe, Olathe
University of Kansas Cancer Center-Overland Park, Overland Park
Salina Regional Health Center, Salina
University of Kansas Health System Saint Francis Campus, Topeka
University of Kansas Hospital-Westwood Cancer Center, Westwood
LouisianaLSU Health Baton Rouge-North Clinic, Baton Rouge
Our Lady of the Lake Physician Group, Baton Rouge
MarylandJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
Walter Reed National Military Medical Center, Bethesda
MichiganUniversity of Michigan Rogel Cancer Center, Ann Arbor
Bronson Battle Creek, Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Henry Ford Cancer Institute-Downriver, Brownstown
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Henry Ford Macomb Hospital-Clinton Township, Clinton Township
Henry Ford Medical Center-Fairlane, Dearborn
Henry Ford Hospital, Detroit
Wayne State University/Karmanos Cancer Institute, Detroit
Weisberg Cancer Treatment Center, Farmington Hills
Cancer Hematology Centers - Flint, Flint
Genesys Hurley Cancer Institute, Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Trinity Health Grand Rapids Hospital, Grand Rapids
Allegiance Health, Jackson
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Trinity Health Muskegon Hospital, Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores
Henry Ford Medical Center-Columbus, Novi
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
Corewell Health Reed City Hospital, Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
Henry Ford Health Providence Southfield Hospital, Southfield
Munson Medical Center, Traverse City
Henry Ford West Bloomfield Hospital, West Bloomfield
Henry Ford Wyandotte Hospital, Wyandotte
University of Michigan Health - West, Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaEssentia Health Saint Joseph's Medical Center, Brainerd
Minnesota Oncology - Burnsville, Burnsville
Mercy Hospital, Coon Rapids
Essentia Health - Deer River Clinic, Deer River
Essentia Health Cancer Center, Duluth
Fairview Southdale Hospital, Edina
Essentia Health Hibbing Clinic, Hibbing
Abbott-Northwestern Hospital, Minneapolis
Mayo Clinic in Rochester, Rochester
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Essentia Health Sandstone, Sandstone
Saint Francis Regional Medical Center, Shakopee
Essentia Health Virginia Clinic, Virginia
MississippiBaptist Memorial Hospital and Cancer Center-Desoto, Southhaven
MissouriSaint Francis Medical Center, Cape Girardeau
Saint Luke's Hospital, Chesterfield
Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Parkland Health Center - Farmington, Farmington
Kansas City Veterans Affairs Medical Center, Kansas City
University Health Truman Medical Center, Kansas City
University of Kansas Cancer Center - Briarcliff, Kansas City
University of Kansas Cancer Center - North, Kansas City
University of Kansas Cancer Center - Lee's Summit, Lee's Summit
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
Missouri Baptist Medical Center, St Louis
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
NevadaOptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyCooperman Barnabas Medical Center, Livingston
Monmouth Medical Center, Long Branch
Rutgers Cancer Institute of New Jersey, New Brunswick
New YorkUniversity of Rochester, Rochester
Wilmot Cancer Institute at Webster, Webster
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
Atrium Health Pineville/LCI-Pineville, Charlotte
Atrium Health University City/LCI-University, Charlotte
Carolinas Medical Center/Levine Cancer Institute, Charlotte
Levine Cancer Institute-SouthPark, Charlotte
Novant Health Presbyterian Medical Center, Charlotte
Wake Forest University at Clemmons, Clemmons
Southeastern Medical Oncology Center-Clinton, Clinton
Atrium Health Cabarrus/LCI-Concord, Concord
Duke University Medical Center, Durham
Southeastern Medical Oncology Center-Goldsboro, Goldsboro
Southeastern Medical Oncology Center-Jacksonville, Jacksonville
Atrium Health Union/LCI-Union, Monroe
Novant Health Cancer Institute - Mooresville, Mooresville
Novant Health Forsyth Medical Center, Winston-Salem
Wake Forest University Health Sciences, Winston-Salem
North DakotaEssentia Health Cancer Center-South University Clinic, Fargo
OhioUH Seidman Cancer Center at UH Avon Health Center, Avon
UHHS-Chagrin Highlands Medical Center, Beachwood
Case Western Reserve University, Cleveland
Ohio State University Comprehensive Cancer Center, Columbus
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonSaint Charles Health System, Bend
Saint Alphonsus Cancer Care Center-Ontario, Ontario
Kaiser Permanente Northwest, Portland
Oregon Health and Science University, Portland
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
PennsylvaniaFox Chase Cancer Center, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
Asplundh Cancer Pavilion, Willow Grove
Rhode IslandRhode Island Hospital, Providence
South CarolinaMedical University of South Carolina, Charleston
TennesseeBaptist Memorial Hospital and Cancer Center-Memphis, Memphis
TexasUT MD Anderson Cancer Center, Houston
University of Texas Health Science Center at San Antonio, San Antonio
UtahHuntsman Cancer Institute/University of Utah, Salt Lake City
VirginiaUniversity of Virginia Cancer Center, Charlottesville
VCU Massey Cancer Center at Stony Point, Richmond
VCU Massey Comprehensive Cancer Center, Richmond
West VirginiaWest Virginia University Charleston Division, Charleston
WisconsinThedaCare Regional Cancer Center, Appleton
ThedaCare Regional Medical Center - Appleton, Appleton
Duluth Clinic Ashland, Ashland
Marshfield Medical Center-EC Cancer Center, Eau Claire
Saint Vincent Hospital Cancer Center Green Bay, Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay
Gundersen Lutheran Medical Center, La Crosse
Marshfield Medical Center-Marshfield, Marshfield
Froedtert Menomonee Falls Hospital, Menomonee Falls
Medical College of Wisconsin, Milwaukee
ProHealth D N Greenwald Center, Mukwonago
Froedtert and MCW Moorland Reserve Health Center, New Berlin
Drexel Town Square Health Center, Oak Creek
ProHealth Oconomowoc Memorial Hospital, Oconomowoc
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls
Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan
Sheboygan Physicians Group, Sheboygan
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay
ProHealth Waukesha Memorial Hospital, Waukesha
UW Cancer Center at ProHealth Care, Waukesha
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend
Marshfield Medical Center - Weston, Weston

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.