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Spots Global Cancer Trial Database for Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Official Title: Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Study ID: NCT04269902

Study Description

Brief Summary: This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Detailed Description: PRIMARY OBJECTIVE: I. To evaluate whether early treatment with venetoclax and obinutuzumab (V-O) extends overall survival (OS) compared with delayed treatment with V-O in high-risk (Chronic Lymphocytic Leukemia \[CLL\] International Prognostic Indicator \[CLL-IPI\] \>= 4 or complex cytogenetics), newly diagnosed asymptomatic CLL/small lymphocytic lymphoma (SLL) patients. SECONDARY OBJECTIVES: I. To compare overall response rates (complete response \[CR\] + partial response \[PR\]), CR rates, progression-free survival (PFS), and event-free survival (EFS) between arms. II. To evaluate safety and tolerability of each arm. III. To compare time to second CLL-directed treatment (from randomization and from response) between arms. IV. To compare relapse-free survival (RFS) and time to second objective disease progression (PFS2) between arms. V. To compare the rates of Richter's transformation between arms. VI. To describe distribution of Cumulative Illness Rating Scale across the study, in each treatment arm, and to estimate the interaction between the scale and treatment arm and OS. PATIENT-REPORTED OUTCOMES OBJECTIVES: I. To assess the impact of early intervention with V-O versus delayed therapy with V-O in CLL patients in relation to Health-Related Quality of Life (HRQoL) using the Functional Assessment of Cancer Therapy (FACT)-Leukemia scale. II. To assess the impact of the two treatment arms on the specific domains of the FACT-Leukemia, including physical, social, emotional, and functional well-being and leukemia-specific HRQoL. TRANSLATIONAL MEDICINE OBJECTIVES (INTEGRATED): I. To evaluate the prognostic association between OS and measurable residual disease (MRD) undetectable disease state at 15 months after treatment initiation, across and between treatment arms. (Primary) II. To describe the prognostic association between the endpoints RFS and OS and MRD undetectable disease state at all measured time points (cycle \[C\]7 day\[D\]1, C9D1, C12D1, and 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, 81, 87, 93, and 99 months after treatment initiation) using landmark analyses, across and between treatment arms. (Secondary) III. To evaluate the prognostic association of MRD undetectable disease state over time in each treatment arm with respect to OS and RFS using time-dependent covariate analyses. (Secondary) IV. To describe the proportion of variation in OS and RFS explained by MRD sampling schemes with the goal of providing information on how much additional variation in OS and RFS is explained by additional MRD sampling for future trial designs. (Secondary) V. To compare the rate of MRD undetectable disease state at 15 months after initiation of treatment between treatment arms. (Secondary) VI. To compare duration of MRD undetectable disease state between treatment arms. (Secondary) VII. To describe associations between pretreatment stimulated karyotype risk, p53 mutation, IGHV mutational analysis, fluorescence in situ hybridization (FISH) for del(13q), del(11q), trisomy 12, and del(17p), and beta-2-microglobulin levels and other biomarkers with OS, PFS, overall and complete response rates, achievement of MRD undetectable disease state, and Richter's transformation. (Secondary) VIII. To describe associations between clinical complete or partial response (by International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] 2018 criteria) and response as assessed by MRD status and CT scans at 15 months after treatment initiation. (Secondary) OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (DELAYED V-O): Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab intravenously (IV) over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax orally (PO) once daily (QD) on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial. ARM II (EARLY V-O): Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial. After completion of study treatment, patients are followed up for 10 years after registration.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

Anchorage Radiation Therapy Center, Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States

Alaska Women's Cancer Care, Anchorage, Alaska, United States

Anchorage Oncology Centre, Anchorage, Alaska, United States

Katmai Oncology Group, Anchorage, Alaska, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Fairbanks Memorial Hospital, Fairbanks, Alaska, United States

Cancer Center at Saint Joseph's, Phoenix, Arizona, United States

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, United States

Kaiser Permanente-Anaheim, Anaheim, California, United States

Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California, United States

Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States

Kaiser Permanente-Bellflower, Bellflower, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States

Marshall Cancer Center, Cameron Park, California, United States

Mercy Cancer Center - Carmichael, Carmichael, California, United States

Mercy San Juan Medical Center, Carmichael, California, United States

UC Irvine Health Cancer Center-Newport, Costa Mesa, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Mercy Cancer Center - Elk Grove, Elk Grove, California, United States

Kaiser Permanente-Fontana, Fontana, California, United States

Kaiser Permanente - Harbor City, Harbor City, California, United States

City of Hope Seacliff, Huntington Beach, California, United States

City of Hope at Irvine Lennar, Irvine, California, United States

Kaiser Permanente-Irvine, Irvine, California, United States

UCI Health Laguna Hills, Laguna Hills, California, United States

City of Hope Antelope Valley, Lancaster, California, United States

City of Hope at Long Beach Elm, Long Beach, California, United States

Tibor Rubin VA Medical Center, Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

Kaiser Permanente West Los Angeles, Los Angeles, California, United States

Fremont - Rideout Cancer Center, Marysville, California, United States

City of Hope Newport Beach, Newport Beach, California, United States

Kaiser Permanente-Ontario, Ontario, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

Stanford Cancer Institute Palo Alto, Palo Alto, California, United States

Kaiser Permanente - Panorama City, Panorama City, California, United States

Kaiser Permanente-Riverside, Riverside, California, United States

Mercy Cancer Center - Rocklin, Rocklin, California, United States

Mercy Cancer Center - Sacramento, Sacramento, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Kaiser Permanente-San Diego Zion, San Diego, California, United States

Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo, California, United States

Kaiser Permanente-San Marcos, San Marcos, California, United States

Mission Hope Medical Oncology - Santa Maria, Santa Maria, California, United States

City of Hope South Pasadena, South Pasadena, California, United States

City of Hope South Bay, Torrance, California, United States

City of Hope Upland, Upland, California, United States

Kaiser Permanente-Woodland Hills, Woodland Hills, California, United States

Woodland Memorial Hospital, Woodland, California, United States

Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, United States

The Medical Center of Aurora, Aurora, Colorado, United States

Boulder Community Foothills Hospital, Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial, Centennial, Colorado, United States

Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States

Cancer Center of Colorado at Sloan's Lake, Denver, Colorado, United States

National Jewish Health-Main Campus, Denver, Colorado, United States

The Women's Imaging Center, Denver, Colorado, United States

Porter Adventist Hospital, Denver, Colorado, United States

Colorado Blood Cancer Institute, Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, United States

SCL Health Saint Joseph Hospital, Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose, Denver, Colorado, United States

Rose Medical Center, Denver, Colorado, United States

Western Surgical Care, Denver, Colorado, United States

Mercy Medical Center, Durango, Colorado, United States

Southwest Oncology PC, Durango, Colorado, United States

Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States

Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, United States

Swedish Medical Center, Englewood, Colorado, United States

The Melanoma and Skin Cancer Institute, Englewood, Colorado, United States

National Jewish Health-Western Hematology Oncology, Golden, Colorado, United States

Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States

Grand Valley Oncology, Grand Junction, Colorado, United States

Banner North Colorado Medical Center, Greeley, Colorado, United States

Good Samaritan Medical Center, Lafayette, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, United States

Saint Anthony Hospital, Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, United States

Littleton Adventist Hospital, Littleton, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, United States

Sky Ridge Medical Center, Lone Tree, Colorado, United States

Longmont United Hospital, Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States

Banner McKee Medical Center, Loveland, Colorado, United States

Parker Adventist Hospital, Parker, Colorado, United States

Saint Mary Corwin Medical Center, Pueblo, Colorado, United States

National Jewish Health-Northern Hematology Oncology, Thornton, Colorado, United States

Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, United States

Beebe South Coastal Health Campus, Frankford, Delaware, United States

Beebe Medical Center, Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States

Helen F Graham Cancer Center, Newark, Delaware, United States

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States

Beebe Health Campus, Rehoboth Beach, Delaware, United States

TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States

Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

Holy Cross Hospital, Fort Lauderdale, Florida, United States

Sacred Heart Hospital, Pensacola, Florida, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital, Emmett, Idaho, United States

Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States

Idaho Urologic Institute-Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States

Kootenai Cancer Clinic, Sandpoint, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States

Saint Anthony's Health, Alton, Illinois, United States

Rush - Copley Medical Center, Aurora, Illinois, United States

Illinois CancerCare-Bloomington, Bloomington, Illinois, United States

Loyola Center for Health at Burr Ridge, Burr Ridge, Illinois, United States

Illinois CancerCare-Canton, Canton, Illinois, United States

Memorial Hospital of Carbondale, Carbondale, Illinois, United States

SIH Cancer Institute, Carterville, Illinois, United States

Illinois CancerCare-Carthage, Carthage, Illinois, United States

Centralia Oncology Clinic, Centralia, Illinois, United States

Northwestern University, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Carle at The Riverfront, Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States

Illinois CancerCare-Dixon, Dixon, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Crossroads Cancer Center, Effingham, Illinois, United States

Elmhurst Memorial Hospital, Elmhurst, Illinois, United States

Illinois CancerCare-Eureka, Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States

Illinois CancerCare-Galesburg, Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States

Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States

Ingalls Memorial Hospital, Harvey, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States

Loyola Medicine Homer Glen, Homer Glen, Illinois, United States

Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States

Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States

Illinois CancerCare-Macomb, Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park, Illinois, United States

Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States

Edward Hospital/Cancer Center, Naperville, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States

Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States

University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States

Illinois CancerCare-Pekin, Pekin, Illinois, United States

Illinois CancerCare-Peoria, Peoria, Illinois, United States

Methodist Medical Center of Illinois, Peoria, Illinois, United States

Illinois CancerCare-Peru, Peru, Illinois, United States

Valley Radiation Oncology, Peru, Illinois, United States

Edward Hospital/Cancer Center?Plainfield, Plainfield, Illinois, United States

Illinois CancerCare-Princeton, Princeton, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Springfield Clinic, Springfield, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

The Carle Foundation Hospital, Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States

Illinois CancerCare - Washington, Washington, Illinois, United States

Rush-Copley Healthcare Center, Yorkville, Illinois, United States

Reid Health, Richmond, Indiana, United States

Mary Greeley Medical Center, Ames, Iowa, United States

McFarland Clinic - Ames, Ames, Iowa, United States

Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States

McFarland Clinic - Boone, Boone, Iowa, United States

Saint Anthony Regional Hospital, Carroll, Iowa, United States

Physicians' Clinic of Iowa PC, Cedar Rapids, Iowa, United States

Mercy Cancer Center-West Lakes, Clive, Iowa, United States

Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States

Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States

Greater Regional Medical Center, Creston, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States

Broadlawns Medical Center, Des Moines, Iowa, United States

Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States

Iowa Lutheran Hospital, Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States

Trinity Regional Medical Center, Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson, Jefferson, Iowa, United States

McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States

Methodist West Hospital, West Des Moines, Iowa, United States

Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States

Central Care Cancer Center - Garden City, Garden City, Kansas, United States

Central Care Cancer Center - Great Bend, Great Bend, Kansas, United States

Flaget Memorial Hospital, Bardstown, Kentucky, United States

Commonwealth Cancer Center-Corbin, Corbin, Kentucky, United States

Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, United States

Saint Joseph Hospital East, Lexington, Kentucky, United States

Saint Joseph London, London, Kentucky, United States

Jewish Hospital, Louisville, Kentucky, United States

Saints Mary and Elizabeth Hospital, Louisville, Kentucky, United States

UofL Health Medical Center Northeast, Louisville, Kentucky, United States

Jewish Hospital Medical Center South, Shepherdsville, Kentucky, United States

Hematology/Oncology Clinic PLLC, Baton Rouge, Louisiana, United States

Ochsner LSU Health Monroe Medical Center, Monroe, Louisiana, United States

Tulane University School of Medicine, New Orleans, Louisiana, United States

Ochsner LSU Health Saint Mary's Medical Center, Shreveport, Louisiana, United States

LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, United States

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Tufts Medical Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Hickman Cancer Center, Adrian, Michigan, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States

Bronson Battle Creek, Battle Creek, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States

Trinity Health Medical Center - Brighton, Brighton, Michigan, United States

Henry Ford Cancer Institute-Downriver, Brownstown, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States

Trinity Health Medical Center - Canton, Canton, Michigan, United States

Caro Cancer Center, Caro, Michigan, United States

Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States

Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, United States

Newland Medical Associates-Clarkston, Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane, Dearborn, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

Ascension Saint John Hospital, Detroit, Michigan, United States

Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, United States

Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States

Genesee Hematology Oncology PC, Flint, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, United States

Academic Hematology Oncology Specialists, Grosse Pointe Woods, Michigan, United States

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States

Michigan Breast Specialists-Grosse Pointe Woods, Grosse Pointe Woods, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Ascension Borgess Cancer Center, Kalamazoo, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

University of Michigan Health - Sparrow Lansing, Lansing, Michigan, United States

Hope Cancer Clinic, Livonia, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States

Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, United States

Michigan Breast Specialists-Macomb Township, Macomb, Michigan, United States

Saint Mary's Oncology/Hematology Associates of Marlette, Marlette, Michigan, United States

Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, United States

Trinity Health Muskegon Hospital, Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital, Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, Michigan, United States

Henry Ford Medical Center-Columbus, Novi, Michigan, United States

Hope Cancer Center, Pontiac, Michigan, United States

Michigan Healthcare Professionals Pontiac, Pontiac, Michigan, United States

Newland Medical Associates-Pontiac, Pontiac, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac, Michigan, United States

Corewell Health Reed City Hospital, Reed City, Michigan, United States

Ascension Saint Mary's Hospital, Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph, Michigan, United States

Henry Ford Macomb Health Center - Shelby Township, Shelby, Michigan, United States

Ascension Providence Hospitals - Southfield, Southfield, Michigan, United States

Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, United States

Ascension Saint Joseph Hospital, Tawas City, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

Advanced Breast Care Center PLLC, Warren, Michigan, United States

Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, United States

Macomb Hematology Oncology PC, Warren, Michigan, United States

Michigan Breast Specialists-Warren, Warren, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States

Saint Mary's Oncology/Hematology Associates of West Branch, West Branch, Michigan, United States

University of Michigan Health - West, Wyoming, Michigan, United States

Huron Gastroenterology PC, Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States

Cambridge Medical Center, Cambridge, Minnesota, United States

Mercy Hospital, Coon Rapids, Minnesota, United States

Essentia Health Cancer Center, Duluth, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Unity Hospital, Fridley, Minnesota, United States

Essentia Health Hibbing Clinic, Hibbing, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center, Minneapolis, Minnesota, United States

Minneapolis VA Medical Center, Minneapolis, Minnesota, United States

Health Partners Inc, Minneapolis, Minnesota, United States

Monticello Cancer Center, Monticello, Minnesota, United States

New Ulm Medical Center, New Ulm, Minnesota, United States

Fairview Northland Medical Center, Princeton, Minnesota, United States

North Memorial Medical Health Center, Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

United Hospital, Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center, Shakopee, Minnesota, United States

Lakeview Hospital, Stillwater, Minnesota, United States

Essentia Health Virginia Clinic, Virginia, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Rice Memorial Hospital, Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States

Fairview Lakes Medical Center, Wyoming, Minnesota, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus, Mississippi, United States

Baptist Cancer Center-Grenada, Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County, New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States

Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States

Saint Francis Medical Center, Cape Girardeau, Missouri, United States

Southeast Cancer Center, Cape Girardeau, Missouri, United States

Saint Luke's Hospital, Chesterfield, Missouri, United States

Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States

Parkland Health Center - Farmington, Farmington, Missouri, United States

MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, United States

Freeman Health System, Joplin, Missouri, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital South, Saint Louis, Missouri, United States

Siteman Cancer Center-South County, Saint Louis, Missouri, United States

Missouri Baptist Medical Center, Saint Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States

Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States

Mercy Hospital Washington, Washington, Missouri, United States

Community Hospital of Anaconda, Anaconda, Montana, United States

Billings Clinic Cancer Center, Billings, Montana, United States

Saint Vincent Healthcare, Billings, Montana, United States

Saint Vincent Frontier Cancer Center, Billings, Montana, United States

Bozeman Health Deaconess Hospital, Bozeman, Montana, United States

Benefis Sletten Cancer Institute, Great Falls, Montana, United States

Great Falls Clinic, Great Falls, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States

Community Medical Center, Missoula, Montana, United States

Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island, Nebraska, United States

CHI Health Good Samaritan, Kearney, Nebraska, United States

Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States

Cancer Partners of Nebraska - Pine Lake, Lincoln, Nebraska, United States

Cancer Partners of Nebraska, Lincoln, Nebraska, United States

Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States

Alegent Health Lakeside Hospital, Omaha, Nebraska, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Midlands Community Hospital, Papillion, Nebraska, United States

OptumCare Cancer Care at Charleston, Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

Jersey City Medical Center, Jersey City, New Jersey, United States

Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States

Monmouth Medical Center, Long Branch, New Jersey, United States

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Community Medical Center, Toms River, New Jersey, United States

MD Anderson Cancer Center at Cooper-Voorhees, Voorhees, New Jersey, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Presbyterian Kaseman Hospital, Albuquerque, New Mexico, United States

Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, United States

Presbyterian Rust Medical Center/Jorgensen Cancer Center, Rio Rancho, New Mexico, United States

Hematology Oncology Associates of Central New York-Auburn, Auburn, New York, United States

Memorial Sloan Kettering Commack, Commack, New York, United States

Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse, New York, United States

Glens Falls Hospital, Glens Falls, New York, United States

Memorial Sloan Kettering Westchester, Harrison, New York, United States

Mount Sinai Hospital, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Upstate Cancer Center at Oswego, Oswego, New York, United States

Rochester General Hospital, Rochester, New York, United States

University of Rochester, Rochester, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

Hematology Oncology Associates of Central New York-Onondaga Hill, Syracuse, New York, United States

SUNY Upstate Medical Center-Community Campus, Syracuse, New York, United States

Memorial Sloan Kettering Nassau, Uniondale, New York, United States

Upstate Cancer Center at Verona, Verona, New York, United States

Wilmot Cancer Institute at Webster, Webster, New York, United States

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States

Durham VA Medical Center, Durham, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States

Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

Vidant Oncology-Kenansville, Kenansville, North Carolina, United States

ECU Health Oncology Kinston, Kinston, North Carolina, United States

Vidant Oncology-Richlands, Richlands, North Carolina, United States

Indu and Raj Soin Medical Center, Beavercreek, Ohio, United States

Strecker Cancer Center-Belpre, Belpre, Ohio, United States

Saint Elizabeth Boardman Hospital, Boardman, Ohio, United States

Cleveland Clinic Mercy Hospital, Canton, Ohio, United States

Mercy Hematology and Oncology Associates Inc, Canton, Ohio, United States

Dayton Physicians LLC-Miami Valley South, Centerville, Ohio, United States

Miami Valley Hospital South, Centerville, Ohio, United States

Adena Regional Medical Center, Chillicothe, Ohio, United States

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, United States

Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States

Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States

Bethesda North Hospital, Cincinnati, Ohio, United States

TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States

TriHealth Cancer Institute-Anderson, Cincinnati, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Mount Carmel East Hospital, Columbus, Ohio, United States

Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Grant Medical Center, Columbus, Ohio, United States

The Mark H Zangmeister Center, Columbus, Ohio, United States

Mount Carmel Health Center West, Columbus, Ohio, United States

Doctors Hospital, Columbus, Ohio, United States

Miami Valley Hospital, Dayton, Ohio, United States

Dayton Physician LLC - Englewood, Dayton, Ohio, United States

Miami Valley Hospital North, Dayton, Ohio, United States

Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States

Grady Memorial Hospital, Delaware, Ohio, United States

Dublin Methodist Hospital, Dublin, Ohio, United States

Armes Family Cancer Center, Findlay, Ohio, United States

Blanchard Valley Hospital, Findlay, Ohio, United States

Orion Cancer Care, Findlay, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States

Dayton Physicians LLC-Atrium, Franklin, Ohio, United States

Central Ohio Breast and Endocrine Surgery, Gahanna, Ohio, United States

Dayton Physicians LLC-Wayne, Greenville, Ohio, United States

Wayne Hospital, Greenville, Ohio, United States

Mount Carmel Grove City Hospital, Grove City, Ohio, United States

Greater Dayton Cancer Center, Kettering, Ohio, United States

Kettering Medical Center, Kettering, Ohio, United States

Fairfield Medical Center, Lancaster, Ohio, United States

Saint Rita's Medical Center, Lima, Ohio, United States

OhioHealth Mansfield Hospital, Mansfield, Ohio, United States

Marietta Memorial Hospital, Marietta, Ohio, United States

OhioHealth Marion General Hospital, Marion, Ohio, United States

Memorial Hospital, Marysville, Ohio, United States

Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States

Knox Community Hospital, Mount Vernon, Ohio, United States

Licking Memorial Hospital, Newark, Ohio, United States

Newark Radiation Oncology, Newark, Ohio, United States

Mercy Health Perrysburg Cancer Center, Perrysburg, Ohio, United States

Southern Ohio Medical Center, Portsmouth, Ohio, United States

Springfield Regional Cancer Center, Springfield, Ohio, United States

Springfield Regional Medical Center, Springfield, Ohio, United States

ProMedica Flower Hospital, Sylvania, Ohio, United States

Mercy Health - Saint Vincent Hospital, Toledo, Ohio, United States

Mercy Health - Saint Anne Hospital, Toledo, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

Dayton Physicians LLC - Troy, Troy, Ohio, United States

Upper Valley Medical Center, Troy, Ohio, United States

Saint Joseph Warren Hospital, Warren, Ohio, United States

University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States

Saint Ann's Hospital, Westerville, Ohio, United States

Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, United States

Saint Elizabeth Youngstown Hospital, Youngstown, Ohio, United States

Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States

Saint Alphonsus Medical Center-Baker City, Baker City, Oregon, United States

Saint Charles Health System, Bend, Oregon, United States

Clackamas Radiation Oncology Center, Clackamas, Oregon, United States

Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States

Bay Area Hospital, Coos Bay, Oregon, United States

Providence Newberg Medical Center, Newberg, Oregon, United States

Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States

Providence Willamette Falls Medical Center, Oregon City, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

Saint Charles Health System-Redmond, Redmond, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States

Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Pocono Medical Center, East Stroudsburg, Pennsylvania, United States

Lehigh Valley Hospital-Hazleton, Hazleton, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital, Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Bristol Regional Medical Center, Bristol, Tennessee, United States

Ballad Health Cancer Care - Kingsport, Kingsport, Tennessee, United States

Wellmont Holston Valley Hospital and Medical Center, Kingsport, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Saint Joseph Regional Cancer Center, Bryan, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

STCC at DHR Health Institute for Research and Development, Edinburg, Texas, United States

UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

Wellmont Medical Associates-Bristol, Bristol, Virginia, United States

Southwest VA Regional Cancer Center, Norton, Virginia, United States

Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States

FHCC Overlake, Bellevue, Washington, United States

PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States

Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States

Highline Medical Center-Main Campus, Burien, Washington, United States

Providence Regional Cancer System-Centralia, Centralia, Washington, United States

Swedish Cancer Institute-Edmonds, Edmonds, Washington, United States

Saint Elizabeth Hospital, Enumclaw, Washington, United States

Providence Regional Cancer Partnership, Everett, Washington, United States

Saint Francis Hospital, Federal Way, Washington, United States

Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States

Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States

FHCC at EvergreenHealth, Kirkland, Washington, United States

Providence Regional Cancer System-Lacey, Lacey, Washington, United States

Saint Clare Hospital, Lakewood, Washington, United States

PeaceHealth Saint John Medical Center, Longview, Washington, United States

Jefferson Healthcare, Port Townsend, Washington, United States

Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States

Pacific Gynecology Specialists, Seattle, Washington, United States

Swedish Medical Center-Ballard Campus, Seattle, Washington, United States

FHCC South Lake Union, Seattle, Washington, United States

Fred Hutchinson Cancer Center, Seattle, Washington, United States

Swedish Medical Center-Cherry Hill, Seattle, Washington, United States

Swedish Medical Center-First Hill, Seattle, Washington, United States

FHCC at Northwest Hospital, Seattle, Washington, United States

University of Washington Medical Center - Montlake, Seattle, Washington, United States

PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States

Providence Regional Cancer System-Shelton, Shelton, Washington, United States

Saint Michael Cancer Center, Silverdale, Washington, United States

Franciscan Research Center-Northwest Medical Plaza, Tacoma, Washington, United States

Northwest Medical Specialties PLLC, Tacoma, Washington, United States

PeaceHealth Southwest Medical Center, Vancouver, Washington, United States

Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States

Providence Regional Cancer System-Yelm, Yelm, Washington, United States

Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States

ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States

HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, United States

Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Aspirus Medford Hospital, Medford, Wisconsin, United States

Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States

Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States

Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States

Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan, Wisconsin, United States

Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States

Aspirus Regional Cancer Center, Wausau, Wisconsin, United States

Marshfield Medical Center - Weston, Weston, Wisconsin, United States

Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States

Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, United States

Billings Clinic-Cody, Cody, Wyoming, United States

Welch Cancer Center, Sheridan, Wyoming, United States

BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Atlantic Health Sciences Corporation-Saint John Regional Hospital, Saint John, New Brunswick, Canada

QEII Health Sciences Centre/Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada

Jewish General Hospital, Montreal, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Contact Details

Name: Deborah M Stephens

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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