coiaward2010

SIMPLICITY (CA180-330)

Study title

SIMPLICITY (CA180-330) = Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting [Europe, Caribbean, Russian Federation, USA]

Scientific title

Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY) (ClinicalTrials.gov NCT01244750)

Indication and most important inclusion criteria

Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below.

To be included in this study. Patients must have been 18 years or older at time of CP-CML diagnosis.

a) Imatinib Groups
Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010. Patients to whom this applies are defined as retrospective Imatinib patients
− Patients who started their first-line Imatinib treatment on or after October 1, 2010

b) Dasatinib Groups
Patients who started their first-line Dasatinib treatment after the drug was approved in this indication

c) Nilotinib Groups
Patients who started their first-line Nilotinib treatment after the drug was approved in this indication

Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site.

Short description of intervention

The purpose of this observational study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

Patients in Group 1 will receive:
Imatinib ≥ 400 mg tablets by mouth once daily or twice daily depending on the dose selected, up to 84 months

Patients in Group 2 will receive:
Dasatinib 100 mg tablet by mouth once daily up to 84 months

Type of study

Other trials

Current status

No longer recruiting

Study sponsor

Bristol-Myers Squibb

Scientific lead / contact

Bristol-Myers Squibb

Principal investigator

See site locations

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Study centers / principal investigators

France

Local Institution
Blois cedex, 41016

Local Institution
Bordeaux, 33300

Local Institution
Chalon/Saone cedex, 71100

Local Institution
Chambéry, 73011

Local Institution
Le Mans Cedex 09, 72037

Local Institution
Pierre Benite cedex, 69495

Local Institution
PRINGY cedex, France, 74374

Germany

Local Institution,
Amberg, 92224

Local Institution
Aschaffenburg, 63739

Local Institution
Baden-Baden, 76530

Local Institution
Bamberg, 96049

Local Institution
Berlin, 12203

Local Institution
Berlin, 13353

Local Institution
Bonn, 53105

Local Institution,
Bottrop, 46236

Local Institution
Coburg, 96450

Local Institution
Darmstadt, 64283

Local Institution
Essen, 45136

Local Institution
Frankfurt am Main,

Local Institution
Frankfurt am Main, 60389

Local Institution
Greifswald, 17475

Local Institution
Hamm, 59063

Local Institution,
Hof, 95028

Local Institution
Idar-Oberstein, 55743

Local Institution
Kaiserslautern, 96049

Local Institution
Kassel, 34117

Local Institution
Koblenz, 56068

Local Institution
Köln, 50674

Local Institution
Köln, 50677

Local Institution
Landshut, 84028

Local Institution
Lebach, 66822

Local Institution
Leipzig, 04103

Local Institution
Mühlheim an der Ruhr, 45468

Local Institution
Offenbach, 63065

Local Institution
Potsdam, 14467

Local Institution
Rostock, 18057

Local Institution
Rötha, 04571

Local Institution
Singen, 78224

Local Institution
Soest, 59494

Local Institution
Ulm, 89081Local Institution
Velbert, 42551

Local Institution
Weiden, 92637

Local Institution
Würzburg, 97080

Italy

Local Institution
Bari, 70124

Local Institution
Brescia, 2123

Local Institution
Brindisi, 72100

Local Institution
Catania, 95124

Local Institution
Florence, 50134

Local Institution
Milan, 20122

Local Institution
Milan, 20162

Local Institution
Modena, 44100

Local Institution
Monza, 20052

Local Institution
Pavia, 27100

Local Institution
Perugia, 06156

Local Institution
Pesaro, 61122

Local Institution
Rionero in Vulture, 85028

Local Institution
Roma, 00189

Local Institution
Roma, 00161

Local Institution
Roma, 00168

Local Institution
Siena, 53100

Local Institution
Terni, 05100

Local Institution
Udine, 33100

Netherlands

Local Institution
Hoofddorp, 2134 TM

Puerto Rico

Puerto Rico Hematology Oncology Group
Bayamon, Puerto Rico, 00961

Russian Federation

Local Institution
Saint-Petersburg, 197022

Spain

Local Institution
La Coruña, 15006

Local Institution
Oviedo - Asturias, 33006

Local Institution
Pamplona, 31008

Local Institution
Salamanca, 37007

Local Institution
Santiago de Compostela, 15706

Local Institution
Toledo, 45004

United States

Alabama
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661

Arizona
Arizona Oncology Associates, PC – HAL
Phoenix, Arizona, 85016

Arizona Oncology Associates, PC – NAHOA
Sedona, Arizona, 86336

Arizona Oncology Associates, PC – HOPE
Tucson, Arizona, 85704

Arkansas
Genesis Cancer Center
Hot Springs National Park, Arkansas, 71913

NEA Baptist Clinic
Jonesboro, Arkansas, 72401

Little Rock Hematology Oncology Associates
Little Rock, Arkansas, 72205

California
Pacific Cancer Medical Center Inc
Anaheim, California, 92801

Southwest Cancer Care Medical Group
Escondido, California, 92025

Wilshire Oncology Medical Group, Inc
Glendora, California, 91741

University of Southern California
Los Angeles, California, 90033

St. Joseph's Hospital
Orange, California, 92868

PMK Medical Group, Inc. DBA Ventura
Oxnard, California, 93030

Stockton Hematology Oncology
Stockton, California, 95204

Tahoe Forest Health System Cancer Center
Truckee, California, 96160

Colorado
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303

Connecticut
Medical Oncology and Blood Disorders, LLP
Manchester, Connecticut, 06040

Stamford Hospital
Stamford, Connecticut, 06904

District of Columbia
George Washington University
Washington, District of Columbia, 20237

Washington Hospital Center, Washington Cancer Institute
Washington D.C, District of Columbia, 20010

Florida
Hematology And Medical Oncology Of Southern Palm Beach County
Boynton Beach, Florida, 33435

Broward Oncology Associates
Fort Lauderdale, Florida,33308

Palm Springs Research Institute
Hialeah, Florida, 33012

University of Florida
Jacksonville, Florida, 32209

Baptist Cancer Institute
Jacksonville, Florida, 32207

Watson Clinic
Lakeland, Florida, 33805

Central Florida Health Alliance
Leesburg, Florida, 34748

Baptist Cancer Center
Miami, Florida

Florida Cancer Specialists
New Port Richey, Florida, 34655

Cancer Centers of Florida
Orlando, Florida, 32806

Lake County Oncology and Hematology
Tavares, Florida, 32778

Space Coast Cancer Center
Titusville, Florida, 32796

Georgia
Emory University
Atlanta, Georgia, 30322

Peachtree Hematology-Oncology
Atlanta, Georgia, 30318

Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060

Georgia Cancer Specialist
Sandy Springs, Georgia, 30342

Lewis Hall Singeltary Oncology Center
Thomasville, Georgia, 31792

Hawaii
Kaiser Permanente Honolulu
Honolulu, Hawaii, 96819

OnCare
Honolulu, Hawaii, 96813

Straub Clinical & Hospital
Honolulu, Hawaii, 96813

Illinois
Mahafzah Medical Center
Evergreen Park, Illinois, 60805

Delnor Community Hospital
Geneva, Illinois, 60134

Orchard Health Care Research
Niles, Illinois, 60076

Mid-Illinois Hem/Onc Asoc
Normal, Illinois, 61761

North Chicago VA Medical Center
North Chicago, Illinois, 60064

Southern Illinois School of Medicine
Springfield, Illinois, 62794

Carle Cancer Center
Urbana, Illinois, 61801

Central DuPage Hospital
Winfield, Illinois, 60190

Indiana
Saint John's Cancer Center
Anderson, Indiana, 46016

Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237

Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46260

Horizon Oncology Research, Inc
Lafayette, Indiana, 47905

Cancer Care Center, Inc. PC
New Albany, Indiana, 47150

Iowa
N. Iowa Mercy Cancer Center
Mason City, Iowa, 50401

Kansas
Hutchinson Clinic
Hutchinson, Kansas, 67502

Cotton O'Neil Cancer Center
Topeka, Kansas, 66606

Cancer Center of Kansas
Wichita, Kansas, 67214

Kentucky
Central Baptist Hospital
Lexington, Kentucky, 40503

University of Louisville Hospital - Brown Cancer Center
Louisville, Kentucky, 40202

Consultants In Blood Disorders
St Matthews, Kentucky, 40207

Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121

Willis-Knighton Cancer System
Shreveport, Louisiana, 71103

Maryland
Maryland Oncology Hematology Pa
Columbia, Maryland, 21044

Frederick Memorial Hospital
Frederick, Maryland, 21701

Massachusetts
Sturdy Hematology & Oncology Associates
Attleboro, Massachusetts, 02703

Boston VA Healthcare System
Boston, Massachusetts, 02130

South Coast Health System
Fall River, Massachusetts, 02720

Commonwealth Hematology-Oncology, P.C.
Quincy, Massachusetts, 02169

UMass Medical Center
Worcester, Massachusetts, 01655

Michigan
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503

West Michigan Cancer Center
Kalamazoo, Michigan, 49007

Michigan State University
Lansing, Michigan, 48910

Mississippi
North Mississippi Hematology & Oncology
Tupelo, Mississippi, 38801

Missouri
St John's Clinic for Cancer and Hematology
Springfield, Missouri, 65807

Montana
Billings Clinic
Billings, Montana, 59101

Nebraska
Omaha VAMC
Omaha, Nebraska, 68105

New Hamphire
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801

New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, 07601

Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, 07962

Southern Oncology Hematology
Vineland, New Jersey, 08360

New York
Montefiore Medical Center / AECOM
Bronx, New York, 10467

Broome Oncology
Johnson City, New York, 13790

St. Lukes Roosevelt Medical Center
New York, New York, 10019

Advanced Oncology
New York, New York, 10013

Vassar Brothers Medical Center
Poughkeepsie, New York, 12601

Stony Brook University Hospital
Stony Brook, New York, 11794

North Carolina
Alamance Regional Cancer Center
Burlington, North Carolina, 27215

Waverly Hematology Oncology
Cary, North Carolina, 27518

Duke University Medical Center
Durham, North Carolina, 27710

Gaston Hematology Oncology
Gastonia, North Carolina, 28054

East Carolina University
Greenville, North Carolina, 27834

Ohio
Akron General Medical Cente
Akron, Ohio, 44302

Gabrail Cancer Center
Canton, Ohio, 44718

Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042

Medical Center of Newark
Newark, Ohio, 43055

Oklahoma
Cancer Care Associates
Tulsa, Oklahoma, 74136

Oregon
Oregon Health & Science University
Portland, Oregon, 97239

Hematology/Oncology Salem LLP
Salem, Oregon, 97301

Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103

St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015

Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704

Lancaster General Health
Lancaster, Pennsylvania, 17601

Veterans Research Foundation of Pittsburgh
Pittsburgh, Pennsylvania, 15240

Berks Hematology-Oncology
West Reading, Pennsylvania, 19611

Geisinger Health System
Wilkes Barre, Pennsylvania, 18711

Cancer Care Association Of York
York, Pennsylvania, 17403

Rhode Island
Hematology and Oncology Associates of RI
Cranston, Rhode Island, 02920

The Cancer Center at Memorial Hospital
Pawtucket, Rhode Island, 02860

South Carolina
Charleston Cancer Center
Charleston, South Carolina, 29406

South Dakota
Avera Research Institute
Sioux Falls, South Dakota, 57105

Prairie Lakes Healthcare System, Inc
Watertown, South Dakota, 57201

Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909

University of Tennessee Medical Center
Knoxville, Tennessee, 37920

Texas
Texas Oncology
Amarillo, Texas, 79106

Texas Oncology - Arlington South
Arlington, Texas, 76014

Texas Oncology-Austin North
Austin, Texas, 78758

Julie & Ben Rogers Cancer Institute
Beaumont, Texas, 77701

Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, 75231

Texas Oncology-Medical City Dallas
Dallas, Texas, 75230-2510

Texas Oncology-Methodist Charlton Cancer Center
Dallas, Texas, 75237

MD Anderson Cancer Center
Houston, Texas, 77030

Michael E Debakey Va Medical Center
Houston, Texas, 77030

Texas Oncology
Lewisville, Texas, 75067

Texas Oncology-McAllen South Second
McAllen, Texas, 78503

Texas Oncology
Mesquite, Texas, 75150

Texas Oncology-Midland Allison Cancer Center
Midland, Texas, 79701

Texas Oncology-Odessa West Texas Cancer Center
Odessa, Texas, 79761

Texas Oncology
Paris, Texas, 75460-5004

North Texas Regional Cancer Center
Plano, Texas, 75075

Cancer Care Centers of South Texas
San Antonio, Texas, 78217

Texas Oncology
Waco, Texas, 76712

Virginia
Danville Hematology & Oncology
Danville, Virginia, 24541

Hematology Oncology Associates of Fredricksburg
Fredericksburg, Virginia, 22408

Peninsula Cancer Institute
Newport News, Virginia, 23601

Blue Ridge Cancer Care
Roanoke, Virginia, 4014

Washington
Swedish Cancer Institute-Eastside Hematology/Oncology
Bellevue, Washington, 98005

Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99208

Wenatchee Valley Medical Center
Wenatchee, Washington, 98801

Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902

West Virginia
Charleston Area Medical Center
Charleston, West Virginia, 25304

City Hospital - West Virginia University Hospital East
Martinsburg, West Virginia, 25401

Wheeling Hospital
Wheeling, West Virginia, 26003

Wisconsin
Aspirus Regional Cancer Center
Wausau, Wisconsin, 53792