Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
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.
Detailed 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 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.
Arms & 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
Outcome measures
Primary
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
Secondary
Overall survival
Time frame: Up to 10 years
Overall response rate
Time frame: At week 40
Event free survival (EFS)
Time frame: From date of registration to date of first occurrence of EFS event, up to 10 years
Incidence of adverse events
Time frame: Up to end of treatment
Restricted chance of longer PFS
Time frame: Up to 10 years
Eligibility criteria
Study locations (267)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Highlands Oncology Group - Rogers
Rogers, Arkansas, 72758
Highlands Oncology Group
Springdale, Arkansas, 72762
Tower Cancer Research Foundation
Beverly Hills, California, 90211
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
City of Hope at Irvine Lennar
Irvine, California, 92618
City of Hope Antelope Valley
Lancaster, California, 93534
City of Hope at Long Beach Elm
Long Beach, California, 90813
Tibor Rubin VA Medical Center
Long Beach, California, 90822
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
City of Hope South Pasadena
South Pasadena, California, 91030
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
City of Hope Upland
Upland, California, 91786
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Medical Center of the Rockies
Loveland, Colorado, 80538
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, 33065
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, 33021
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Mount Sinai Medical Center
Miami Beach, Florida, 33140
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, 33181
Memorial Hospital West
Pembroke Pines, Florida, 33028
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Augusta University Medical Center
Augusta, Georgia, 30912
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Illinois CancerCare-Canton
Canton, Illinois, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Swedish Covenant Hospital
Chicago, Illinois, 60625
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Carle at The Riverfront
Danville, Illinois, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Memorial Hospital East
Shiloh, Illinois, 62269
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Carle Cancer Center
Urbana, Illinois, 61801
Illinois CancerCare - Washington
Washington, Illinois, 61571
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Northwest Oncology LLC
Dyer, Indiana, 46311
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
Saint Mary Medical Center
Hobart, Indiana, 46342
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Saint Catherine Hospital
Indianapolis, Indiana, 46312
The Community Hospital
Munster, Indiana, 46321
Women's Diagnostic Center - Munster
Munster, Indiana, 46321
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
McFarland Clinic - Boone
Boone, Iowa, 50036
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
HaysMed
Hays, Kansas, 67601
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Veteran Administration Eastern Kansas Healthcare
Leavenworth, Kansas, 66048
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, 66061
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Salina Regional Health Center
Salina, Kansas, 67401
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Bronson Battle Creek
Battle Creek, Michigan, 49017
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Allegiance Health
Jackson, Michigan, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Hope Cancer Center
Pontiac, Michigan, 48341
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075
Munson Medical Center
Traverse City, Michigan, 49684
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
University of Michigan Health - West
Wyoming, Michigan, 49519
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Mercy Hospital
Coon Rapids, Minnesota, 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Fairview Southdale Hospital
Edina, Minnesota, 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Parkland Health Center - Farmington
Farmington, Missouri, 63640
University Health Truman Medical Center
Kansas City, Missouri, 64108
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
Community Hospital of Anaconda
Anaconda, Montana, 59711
Billings Clinic Cancer Center
Billings, Montana, 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Logan Health Medical Center
Kalispell, Montana, 59901
Community Medical Center
Missoula, Montana, 59804
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Monmouth Medical Center
Long Branch, New Jersey, 07740
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of Rochester
Rochester, New York, 14642
Wilmot Cancer Institute at Webster
Webster, New York, 14580
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Duke University Medical Center
Durham, North Carolina, 27710
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, 28117
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence Newberg Medical Center
Newberg, Oregon, 97132
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Kaiser Permanente Northwest
Portland, Oregon, 97227
Oregon Health and Science University
Portland, Oregon, 97239
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Rhode Island Hospital
Providence, Rhode Island, 02903
Medical University of South Carolina
Charleston, South Carolina, 29425
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
UT MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
West Virginia University Charleston Division
Charleston, West Virginia, 25304
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
ThedaCare Regional Medical Center - Appleton
Appleton, Wisconsin, 54911
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476