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Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244750
Recruitment Status : Unknown
Verified January 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2010
Last Update Posted : January 23, 2018
ICON Clinical Research
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this 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.

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Other: Non-Interventional

Detailed Description:
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)

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Study Type : Observational
Actual Enrollment : 1494 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
Actual Study Start Date : December 2, 2010
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : August 30, 2020

Group/Cohort Intervention/treatment
First line TKI treatment: Imatinib
Diagnosed CML patients who receive first line TKI treatment: Imatinib
Other: Non-Interventional

First line TKI treatment: Nilotinib
Diagnosed CML patients who receive first line TKI treatment: Nilotinib
Other: Non-Interventional

First line TKI treatment: Dasatinib
Diagnosed CML patients who receive first line TKI treatment: Dasatinib
Other: Non-Interventional

Imatinib treated patients
Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010
Other: Non-Interventional

Primary Outcome Measures :
  1. The rate of Complete Cytogenetic Response [ Time Frame: 12 months ]
  2. The duration of initial TKI treatment [ Time Frame: 5-years from study index date ]
    Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)

  3. The rate of discontinuation and treatment changes after initial TKI treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ]
    Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)

  4. The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response) [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ]
    Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam

  5. The adherence to treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ]
    Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.

Secondary Outcome Measures :
  1. Impact of first-line treatment options on quality of life [ Time Frame: Every 6 months ]

    Questionnaires used for assessment:

    Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).

  2. Non-hematologic side effects from treatment affecting patient quality of life and outcomes [ Time Frame: Every 6 months ]
    Treatment discontinuations and changes

  3. Patient satisfaction with CML treatment [ Time Frame: Every 6 months ]
    Cancer Therapy Satisfaction Questionnaire (CTSQ)

  4. Patterns of disease monitoring as observed in a real-world setting [ Time Frame: Every 6 months ]
    MD Anderson Symptom Inventory - CML (MDASI-CML) Questionnaire - disease-specific module of the MDASI7 which is a brief measure of severity and impact of cancer-related symptoms on daily function

  5. Resource utilization associated with CML management [ Time Frame: Every 6 months ]
    To evaluate healthcare resource utilization, descriptive statistics will describe real-world disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited at oncology practices or oncology centers linked to a hospital in the North Americas, Europe and potentially at additional sites in South America, and Asia

For more information regarding BMS clinical trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01244750

Hide Hide 214 study locations
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United States, Alabama
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States, 85016
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States, 86336
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85704
United States, Arkansas
Genesis Cancer Center
Hot Springs National Park, Arkansas, United States, 71913
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, United States, 72205
United States, California
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
Southwest Cancer Care Medical Group
Escondido, California, United States, 92025
Wilshire Oncology Medical Group, Inc
Glendora, California, United States, 91741
University of Southern California
Los Angeles, California, United States, 90033
St. Joseph's Hospital
Orange, California, United States, 92868
PMK Medical Group, Inc. DBA Ventura
Oxnard, California, United States, 93030
Stockton Hematology Oncology
Stockton, California, United States, 95204
Tahoe Forest Health System Cancer Center
Truckee, California, United States, 96160
United States, Colorado
Rocky Mountain Cancer Centers
Boulder, Colorado, United States, 80303
United States, Connecticut
Medical Oncology and Blood Disorders, LLP
Manchester, Connecticut, United States, 06040
Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, District of Columbia
Washington Hospital Center, Washington Cancer Institute
Washington, District of Columbia, United States, 20010
George Washington University
Washington, District of Columbia, United States, 20237
United States, Florida
Hematology And Medical Oncology Of Southern Palm Beach County
Boynton Beach, Florida, United States, 33435
Broward Oncology Associates
Fort Lauderdale, Florida, United States, 33308
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
University Of Florida
Jacksonville, Florida, United States, 32209
Watson Clinic
Lakeland, Florida, United States, 33805
Central Florida Health Alliance
Leesburg, Florida, United States, 34748
Baptist Cancer Center
Miami, Florida, United States
Florida Cancer Specialists
New Port Richey, Florida, United States, 34655
Cancer Centers of Florida
Orlando, Florida, United States, 32806
Lake County Oncology and Hematology
Tavares, Florida, United States, 32778
Space Coast Cancer Center
Titusville, Florida, United States, 32796
United States, Georgia
Peachtree Hematology-Oncology
Atlanta, Georgia, United States, 30318
Emory University
Atlanta, Georgia, United States, 30322
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
Georgia Cancer Specialist
Sandy Springs, Georgia, United States, 30342
Lewis Hall Singeltary Oncology Center
Thomasville, Georgia, United States, 31792
United States, Hawaii
Honolulu, Hawaii, United States, 96813
Straub Clinical & Hospital
Honolulu, Hawaii, United States, 96813
Kaiser Permanente Honolulu
Honolulu, Hawaii, United States, 96819
United States, Illinois
Mahafzah Medical Center
Evergreen Park, Illinois, United States, 60805
Delnor Community Hospital
Geneva, Illinois, United States, 60134
Orchard Health Care Research
Niles, Illinois, United States, 60076
Mid-Illinois Hem/Onc Asoc
Normal, Illinois, United States, 61761
North Chicago VA Medical Center
North Chicago, Illinois, United States, 60064
Southern Illinois School of Medicine
Springfield, Illinois, United States, 62794
Carle Cancer Center
Urbana, Illinois, United States, 61801
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
Saint John's Cancer Center
Anderson, Indiana, United States, 46016
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States, 46260
Horizon Oncology Research, Inc
Lafayette, Indiana, United States, 47905
Cancer Care Center, Inc. PC
New Albany, Indiana, United States, 47150
United States, Iowa
N. Iowa Mercy Cancer Center
Mason City, Iowa, United States, 50401
United States, Kansas
Hutchinson Clinic
Hutchinson, Kansas, United States, 67502
Cotton O'Neil Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
University of Louisville Hospital - Brown Cancer Center
Louisville, Kentucky, United States, 40202
Consultants In Blood Disorders
Saint Matthews, Kentucky, United States, 40207
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Willis-Knighton Cancer System
Shreveport, Louisiana, United States, 71103
United States, Maryland
Maryland Oncology Hematology Pa
Columbia, Maryland, United States, 21044
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
United States, Massachusetts
Sturdy Hematology & Oncology Associates
Attleboro, Massachusetts, United States, 02703
Boston VA Healthcare System
Boston, Massachusetts, United States, 02130
South Coast Health System
Fall River, Massachusetts, United States, 02720
Commonwealth Hematology-Oncology, P.C.
Quincy, Massachusetts, United States, 02169
UMass Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Michigan State University
Lansing, Michigan, United States, 48910
United States, Mississippi
North Mississippi Hematology & Oncology
Tupelo, Mississippi, United States, 38801
United States, Missouri
St John's Clinic for Cancer and Hematology
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Nebraska
Omaha VAMC
Omaha, Nebraska, United States, 68105
United States, New Hampshire
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, United States, 07962
Southern Oncology Hematology
Vineland, New Jersey, United States, 08360
United States, New York
Montefiore Medical Center / AECOM
Bronx, New York, United States, 10467
Broome Oncology
Johnson City, New York, United States, 13790
Advanced Oncology
New York, New York, United States, 10013
St. Lukes Roosevelt Medical Center
New York, New York, United States, 10019
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
Alamance Regional Cancer Center
Burlington, North Carolina, United States, 27215
Waverly Hematology Oncology
Cary, North Carolina, United States, 27518
Duke University Medical Center
Durham, North Carolina, United States, 27710
Gaston Hematology Oncology
Gastonia, North Carolina, United States, 28054
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44302
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
Medical Center of Newark
Newark, Ohio, United States, 43055
United States, Oklahoma
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Hematology/Oncology Salem LLP
Salem, Oregon, United States, 97301
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
Lancaster General Health
Lancaster, Pennsylvania, United States, 17601
Veterans Research Foundation of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
Berks Hematology-Oncology
West Reading, Pennsylvania, United States, 19611
Geisinger Health System
Wilkes-Barre, Pennsylvania, United States, 18711
Cancer Care Association Of York
York, Pennsylvania, United States, 17403
United States, Rhode Island
Hematology and Oncology Associates of RI
Cranston, Rhode Island, United States, 02920
The Cancer Center at Memorial Hospital
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Prairie Lakes Healthcare System, Inc
Watertown, South Dakota, United States, 57201
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Oncology
Amarillo, Texas, United States, 79106
Texas Oncology - Arlington South
Arlington, Texas, United States, 76014
Texas Oncology-Austin North
Austin, Texas, United States, 78758
Julie & Ben Rogers Cancer Institute
Beaumont, Texas, United States, 77701
Texas Oncology-Medical City Dallas
Dallas, Texas, United States, 75230-2510
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Methodist Charlton Cancer Center
Dallas, Texas, United States, 75237
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Michael DeBakey VA Medical Center
Houston, Texas, United States, 77030
Texas Oncology
Lewisville, Texas, United States, 75067
Texas Oncology-McAllen South Second
McAllen, Texas, United States, 78503
Texas Oncology
Mesquite, Texas, United States, 75150
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, United States, 79701
Texas Oncology-Odessa West Texas Cancer Center
Odessa, Texas, United States, 79761
Texas Oncology
Paris, Texas, United States, 75460-5004
North Texas Regional Cancer Center
Plano, Texas, United States, 75075
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology
Waco, Texas, United States, 76712
United States, Virginia
Danville Hematology & Oncology
Danville, Virginia, United States, 24541
Hematology Oncology Associates of Fredricksburg
Fredericksburg, Virginia, United States, 22408
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
United States, Washington
Swedish Cancer Institute-Eastside Hematology/Oncology
Bellevue, Washington, United States, 98005
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99208
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
City Hospital - West Virginia University Hospital East
Martinsburg, West Virginia, United States, 25401
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 53792
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Blois cedex, France, 41016
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Bordeaux, France, 33300
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Chalon/Saone Cedex, France, 71100
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Chambéry, France, 73011
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Le Mans Cedex 09, France, 72037
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Pierre Benite, France, 69495
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PRINGY cedex, France, 74374
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Amberg, Germany, 92224
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Aschaffenburg, Germany
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Baden-Baden, Germany
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Bamberg, Germany, 96049
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Berlin, Germany, 12203
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Berlin, Germany, 13353
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Bonn, Germany, 53105
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Bottrop, Germany, 46236
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Coburg, Germany, 96450
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Darmstadt, Germany, 64283
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Essen, Germany, 45136
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Frankfurt am Main, Germany
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Frankurt am Main, Germany, 60389
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Greifswald, Germany, 17475
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Hamm, Germany, 59063
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Hof, Germany, 95028
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Idar-Oberstein, Germany, 55743
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Kaiserslautern, Germany
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Kassel, Germany, 34117
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Koblenz, Germany, 56068
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Köln, Germany, 50674
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Köln, Germany, 50677
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Landshut, Germany, 84028
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Lebach, Germany, 66822
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Leipzig, Germany, 04103
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Mülheim A. D. Ruhr, Germany, 45468
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Offenbach, Germany
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Potsdam, Germany, 14467
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Rostock, Germany, 18057
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Rötha, Germany, 04571
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Singen, Germany, 78224
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Soest, Germany, 59494
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Ulm, Germany, 89081
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Velbert, Germany, 42551
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Weiden, Germany, 92637
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Würzburg, Germany, 97080
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Bari, Italy, 70124
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Brescia, Italy, 25123
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Brindisi, Italy, 72100
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Catania, Italy, 95124
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Florence, Italy, 50134
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Milano, Italy, 20162
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Milan, Italy, 20122
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Modena, Italy, 44100
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Monza, Italy, 20052
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Pavia, Italy, 27100
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Perugia, Italy, 06156
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Pesaro, Italy, 61122
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Rionero in Vulture, Italy, 85028
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Roma, Italy, 00189
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Rome, Italy, 00161
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Rome, Italy, 00168
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Siena, Italy, 53100
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Terni, Italy, 05100
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Udine, Italy, 33100
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Hoofddorp, Netherlands, 2134 TM
Puerto Rico
Puerto Rico Hematology Oncology Group
Bayamon, Puerto Rico, 00961
Russian Federation
Local Institution
Saint-Petersburg, Russian Federation, 197022
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La Coruña, Spain, 15006
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Oviedo - Asturias, Spain, 33006
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Pamplona, Spain, 31008
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Salamanca, Spain, 37007
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Santiago De Compostela-A Coruña, Spain, 15706
Local Insitution
Toledo, Spain, 45004
Sponsors and Collaborators
Bristol-Myers Squibb
ICON Clinical Research
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb Identifier: NCT01244750    
Other Study ID Numbers: CA180-330
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Keywords provided by Bristol-Myers Squibb:
Chronic Phase - Chronic Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases