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


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

Thank you

Trial Information

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


Time Perspective : Most patients are expected to be a mix of retrospective and prospective
data collection. Patients can be enrolled after their study index date (retrospective
component) and have to be followed until 5 years from study index date are complete (time
between enrollment and 5 year follow-up is the prospective component)


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

- 18 years or older at time of of CP-CML diagnosis

a) Imatinib Cohorts

- Patients who started their first-line Imatinib treatment between January 2, 2008 and
September 30, 2010.Patients fitting this criterion are defined as retrospective
Imatinib patients

− Patients who started their first-line Imatinib treatment on or after October 1,
2010

b) Dasatinib Cohort

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

c) Nilotinib Cohort

- 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 for data entry into the study
Electronic Case Report Form (eCRF)

- Receiving treatment at medical practice (eg. community-based, office-based,
hospital-based, academic setting, oncology center)

Exclusion Criteria:

- Patients who are participating in an interventional trial which may influence the
management of their CML disease will be excluded

Discontinuation Criteria:

- Enrolled patients who join an interventional trial which may influence the management
of their CML disease will be excluded at the time of entry into the interventional
trial

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

The rate of Complete Cytogenetic Response

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Institutional Review Board

Study ID:

CA180-330

NCT ID:

NCT01244750

Start Date:

October 2010

Completion Date:

December 2017

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic Phase - Chronic Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Akron General Medical Center Akron, Ohio  44302
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Michigan State University East Lansing, Michigan  48824
Hackensack University Medical Center Hackensack, New Jersey  07601
Ochsner Clinic Foundation New Orleans, Louisiana  70121
Thompson Cancer Survival Center Knoxville, Tennessee  37916
Central Baptist Hospital Lexington, Kentucky  40503
Vassar Brothers Medical Center Poughkeepsie, New York  12601
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
Charleston Area Medical Center Charleston, West Virginia  25304
Florida Cancer Specialists Fort Myers, Florida  33901
Carle Cancer Center Urbana, Illinois  61801
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Watson Clinic Lakeland, Florida  33805
Indiana Blood and Marrow Transplantation Indianapolis, Indiana  46202
Genesis Cancer Center Hot Springs, Arkansas  71913
Tennessee Cancer Specialists Knoxville, Tennessee  37920
Oregon Health & Science University Portland, Oregon  97201
Duke University Medical Center Durham, North Carolina  27710
Cancer Care Associates Tulsa, Oklahoma  74136
University of Florida Gainesville, Florida  32610-0277
Georgia Cancer Specialist Marietta, Georgia  30060
Emory University Atlanta, Georgia  30322
Charleston Cancer Center Charleston, South Carolina  29406
Broward Oncology Associates Ft. Lauderdale, Florida  33308
Consultants in Blood Disorders Louisville, Kentucky  40207
Cancer Centers of Florida Orlando, Florida  32806
Stony Brook University Hospital Stony Brook, New York  11794-8174
St. Luke's Hospital and Health Network Bethlehem, Pennsylvania  18015
Texas Oncology Dallas, Texas  
George Washington University Washington, District of Columbia  20037
North Texas Regional Cancer Center Plano, Texas  75075
Gabrail Cancer Center Canton, Ohio  44718
Avera Research Institute Sioux Falls, South Dakota  57105
Cancer & Hematology Centers of Western Michigan Grand Rapids, Michigan  49546
Hematology-Oncology Associates of Northern NJ, PA Morristown, New Jersey  07962
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
Frederick Memorial Hospital Frederick, Maryland  21701
Peninsula Cancer Institute Newport News, Virginia  23601
Broome Oncology Johnson City, New York  13790
Little Rock Hematology Oncology Associates Little Rock, Arkansas  72205
University of Southern California Los Angeles, California  90033
Billings Clinic Billings, Montana  59107-7000
Portsmouth Regional Hospital Portsmouth, New Hampshire  03802
Wheeling Hospital Wheeling, West Virginia  26003
Aspirus Regional Cancer Center Wausau, Wisconsin  54401
Cancer Center of Kansas Wichita, Kansas  67214
Baptist Cancer Institute Jacksonville, Florida  32207
Northwest Alabama Cancer Center Muscle Shoals, Alabama  35661
Cancer Care Centers of South Texas San Antonio, Texas  78229
Investigative Clinical Research of Indiana Indianapolis, Indiana  46254
Cancer Outreach Associates Abingdon, Virginia  24211
University of Tennessee Medical Center Knoxville, Tennessee  37920
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
Delnor Community Hospital Geneva, Illinois  60134
East Carolina University Greenville, North Carolina  27858
Texas Oncology-Austin North Austin, Texas  78759
Southwest Cancer Care Medical Group Poway, California  92064-2527
Stockton Hematology Oncology Stockton, California  95204
Waverly Hematology Oncology Cary, North Carolina  27518
Pacific Cancer Medical Center, Inc Anaheim, California  92801
Northwest Georgia Oncology Centers, PC Marietta, Georgia  30060
Baptist Cancer Center Jacksonville, Florida  32209
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
Blue Ridge Cancer Care Roanoke, Virginia  24019
Geisinger Health System Wilkes Barre, Pennsylvania  18711
Wilshire Oncology Medical Group, Inc LaVerne, California  91750
Palm Springs Research Institute Hialeah, Florida  33012
Boston VA Healthcare System Boston, Massachusetts  02130
Danville Hematology & Oncology Danville, Virginia  24541
Hutchinson Clinic Hutchinson, Kansas  67502
Lake County Oncology and Hematology The Villages, Florida  32159
Texas Oncology - Arlington South Arlington, Texas  76014-2084
Central DuPage Hospital Winfield, Illinois  60190
North Chicago VA Medical Center North Chicago, Illinois  60064
Cotton O'Neil Cancer Center Topeka, Kansas  66606
Maryland Oncology Hematology PA Columbia, Maryland  21044
Omaha VAMC Omaha, Nebraska  68105
NEA Baptist Clinic Jonesboro, Arkansas  72401
Arizona Oncology Associates, PC - NAHOA Sedona, Arizona  86336
Arizona Oncology Associates, PC - HOPE Tucson, Arizona  85704
Texas Oncology-Methodist Charlton Cancer Center Dallas, Texas  75237
Texas Oncology-Dallas Presbyterian Hospital Dallas, Texas  75231
Texas Oncology-Midland Allison Cancer Center Midland, Texas  79701
Medical Oncology and Blood Disorders, LLP Manchester, Connecticut  06040
Space Coast Cancer Center Titusville, Florida  32796
St. Joseph's Hospital Orange, California  92868
PMK Medical Group, Inc. DBA Ventura Oxnard, California  93030
Tahoe Forest Health System Cancer Center Truckee, California  96160
Washington Hospital Center, Washington Cancer Institute Washington D.C, District of Columbia  20010
Hematology And Medical Oncology Of Southern Palm Beach County Boynton Beach, Florida  33435
Peachtree Hematology-Oncology Atlanta, Georgia  30318
Straub Clinical & Hospital Honolulu, Hawaii  96813
OnCare Honolulu, Hawaii  96813
Kaiser Permanente Honolulu Honolulu, Hawaii  96819
Mahafzah Medical Center Evergreen Park, Illinois  60805
Orchard Health Care Research Niles, Illinois  60076
Mid-Illinois Hem/Onc Asoc Normal, Illinois  61761
Saint John's Cancer Center Anderson, Indiana  46016
Horizon Oncology Research, Inc Lafayette, Indiana  47905
Cancer Care Center, Inc. PC New Albany, Indiana  47150
N. Iowa Mercy Cancer Center Mason City, Iowa  50401
University of Louisville Hospital - Brown Cancer Center Louisville, Kentucky  40202
Willis-Knighton Cancer System Shreveport, Louisiana  71103
Sturdy Hematology & Oncology Associates Attleboro, Massachusetts  02703
Commonwealth Hematology-Oncology, P.C. Quincy, Massachusetts  02169
UMass Medical Center Worcester, Massachusetts  01655
St John's Clinic for Cancer and Hematology Springfield, Missouri  65807
Southern Oncology Hematology Vineland, New Jersey  08360
Montefiore Medical Center / AECOM Bronx, New York  10467
Advanced Oncology New York, New York  10013
St. Lukes Roosevelt Medical Center New York, New York  10019
Alamance Regional Cancer Center Burlington, North Carolina  27215
Gaston Hematology Oncology Gastonia, North Carolina  28054
Medical Center of Newark Newark, Ohio  43055
Hematology/Oncology Salem LLP Salem, Oregon  97301
Lancaster General Health Lancaster, Pennsylvania  17601
Veterans Research Foundation of Pittsburgh Pittsburgh, Pennsylvania  15240
Berks Hematology-Oncology West Reading, Pennsylvania  19611
Cancer Care Association Of York York, Pennsylvania  17403
Hematology and Oncology Associates of RI Cranston, Rhode Island  02920
The Cancer Center at Memorial Hospital Pawtucket, Rhode Island  02860
Prairie Lakes Healthcare System, Inc Watertown, South Dakota  57201
Integrity Oncology Memphis, Tennessee  38120
Julie & Ben Rogers Cancer Institute Beaumont, Texas  77701
Texas Oncology-Medical City Dallas Dallas, Texas  75230-2510
Michael DeBakey VA Medical Center Houston, Texas  77030
Texas Oncology-McAllen South Second McAllen, Texas  78503
Texas Oncology-Odessa West Texas Cancer Center Odessa, Texas  79761
Hematology Oncology Associates of Fredricksburg Fredericksburg, Virginia  22408
Swedish Cancer Institute-Eastside Hematology/Oncology Bellevue, Washington  98005
City Hospital - West Virginia University Hospital East Martinsburg, West Virginia  25401
Arizona Oncology Associates, PC - HAL Phoenix, Arizona  85016
Central Florida Health Alliance Leesburg, Florida  34748
Lewis Hall Singeltary Oncology Center Thomasville, Georgia  31792
Southern Illinois School of Medicine Springfield, Illinois  62794
South Coast Health System Fall River, Massachusetts  02720
North Mississippi Hematology & Oncology Tupelo, Mississippi  38801