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Trial record 1 of 1 for:    The 5-Year Prospective Cohort Study (Simplicity)
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Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting (SIMPLICITY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01244750
First received: November 15, 2010
Last updated: March 18, 2016
Last verified: March 2016
  Purpose
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
Chronic Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The rate of Complete Cytogenetic Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The duration of initial TKI treatment [ Time Frame: 5-years from study index date ] [ Designated as safety issue: No ]
    Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)

  • 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 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam

  • The adherence to treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ] [ Designated as safety issue: No ]
    Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.


Secondary Outcome Measures:
  • Impact of first-line treatment options on quality of life [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

    Questionnaires used for assessment:

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


  • Non-hematologic side effects from treatment affecting patient quality of life and outcomes [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Treatment discontinuations and changes

  • Patient satisfaction with CML treatment [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    Cancer Therapy Satisfaction Questionnaire (CTSQ)

  • Patterns of disease monitoring as observed in a real-world setting [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    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

  • Resource utilization associated with CML management [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 1494
Study Start Date: December 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
First line TKI treatment: Imatinib
Diagnosed CML patients who receive first line TKI treatment: Imatinib
First line TKI treatment: Nilotinib
Diagnosed CML patients who receive first line TKI treatment: Nilotinib
First line TKI treatment: Dasatinib
Diagnosed CML patients who receive first line TKI treatment: Dasatinib
Imatinib treated patients
Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010

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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Criteria

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244750

  Hide Study Locations
Locations
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 D.C, 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
OnCare
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
St 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
France
Local Institution
Blois cedex, France, 41016
Local Institution
Bordeaux, France, 33300
Local Institution
Chalon/Saone cedex, France, 71100
Local Institution
Chambéry, France, 73011
Local Institution
Le Mans Cedex 09, France, 72037
Local Institution
Pierre Benite, France, 69495
Local Institution
PRINGY cedex, France, 74374
Germany
Local Institution
Amberg, Germany, 92224
Local Institution
Aschaffenburg, Germany
Local Institution
Baden-Baden, Germany
Local Institution
Bamberg, Germany, 96049
Local Institution
Berlin, Germany, 12203
Local Institution
Berlin, Germany, 13353
Local Institution
Bonn, Germany, 53105
Local Institution
Bottrop, Germany, 46236
Local Institution
Coburg, Germany, 96450
Local Institution
Darmstadt, Germany, 64283
Local Institution
Essen, Germany, 45136
Local Institution
Frankfurt am Main, Germany
Local Institution
Frankurt am Main, Germany, 60389
Local Institution
Greifswald, Germany, 17475
Local Institution
Hamm, Germany, 59063
Local Institution
Hof, Germany, 95028
Local Institution
Idar-Oberstein, Germany, 55743
Local Institution
Kaiserslautern, Germany
Local Institution
Kassel, Germany, 34117
Local Institution
Koblenz, Germany, 56068
Local Institution
Köln, Germany, 50674
Local Institution
Köln, Germany, 50677
Local Institution
Landshut, Germany, 84028
Local Institution
Lebach, Germany, 66822
Local Institution
Leipzig, Germany, 04103
Local Institution
Mülheim a. d. Ruhr, Germany, 45468
Local Institution
Offenbach, Germany
Local Institution
Potsdam, Germany, 14467
Local Institution
Rostock, Germany, 18057
Local Institution
Rötha, Germany, 04571
Local Institution
Singen, Germany, 78224
Local Institution
Soest, Germany, 59494
Local Institution
Ulm, Germany, 89081
Local Institution
Velbert, Germany, 42551
Local Institution
Weiden, Germany, 92637
Local Institution
Würzburg, Germany, 97080
Italy
Local Institution
Bari, Italy, 70124
Local Institution
Brescia, Italy, 25123
Local Institution
Brindisi, Italy, 72100
Local Institution
Catania, Italy, 95124
Local Institution
Florence, Italy, 50134
Local Institution
Milano, Italy, 20162
Local Institution
Milan, Italy, 20122
Local Institution
Modena, Italy, 44100
Local Institution
Monza, Italy, 20052
Local Institution
Pavia, Italy, 27100
Local Institution
Perugia, Italy, 06156
Local Institution
Pesaro, Italy, 61122
Local Institution
Rionero in Vulture, Italy, 85028
Local Institution
Roma, Italy, 00189
Local Institution
Rome, Italy, 00161
Local Institution
Rome, Italy, 00168
Local Institution
Siena, Italy, 53100
Local Institution
Terni, Italy, 05100
Local Institution
Udine, Italy, 33100
Netherlands
Local Institution
Hoofddorp, Netherlands, 2134 TM
Puerto Rico
Puerto Rico Hematology Oncology Group
Bayamon, Puerto Rico, 00961
Russian Federation
Local Institution
Saint-Petersburg, Russian Federation, 197022
Spain
Local Institution
La Coruña, Spain, 15006
Local Institution
Oviedo - Asturias, Spain, 33006
Local Institution
Pamplona, Spain, 31008
Local Institution
Salamanca, Spain, 37007
Local Institution
Santiago de Compostela-A Coruña, Spain, 15706
Local Insitution
Toledo, Spain, 45004
Sponsors and Collaborators
Bristol-Myers Squibb
ICON Clinical Research
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01244750     History of Changes
Other Study ID Numbers: CA180-330 
Study First Received: November 15, 2010
Last Updated: March 18, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Chronic Phase - Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016