Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
SIMPLICITY
Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
1 other identifier
observational
1,494
8 countries
214
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
214 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedStudy Start
First participant enrolled
December 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2020
CompletedJune 30, 2022
June 1, 2022
9.1 years
November 15, 2010
June 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
The rate of Complete Cytogenetic Response
12 months
The duration of initial TKI treatment
Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
5-years from study index date
The rate of discontinuation and treatment changes after initial TKI treatment
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)
Every 6 months for a follow-up period of 5-years from study index date
The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)
Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam
Every 6 months for a follow-up period of 5-years from study index date
The adherence to treatment
Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
Every 6 months for a follow-up period of 5-years from study index date
Secondary Outcomes (5)
Impact of first-line treatment options on quality of life
Every 6 months
Non-hematologic side effects from treatment affecting patient quality of life and outcomes
Every 6 months
Patient satisfaction with CML treatment
Every 6 months
Patterns of disease monitoring as observed in a real-world setting
Every 6 months
Resource utilization associated with CML management
Every 6 months
Study Arms (4)
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
Eligibility Criteria
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
You may qualify if:
- 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
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- ICON Clinical Researchcollaborator
Study Sites (214)
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, 86336, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, 72205, United States
Pacific Cancer Medical Center, Inc
Anaheim, California, 92801, United States
Southwest Cancer Care Medical Group
Escondido, California, 92025, United States
Wilshire Oncology Medical Group, Inc
Glendora, California, 91741, United States
University of Southern California
Los Angeles, California, 90033, United States
St. Joseph's Hospital
Orange, California, 92868, United States
PMK Medical Group, Inc. DBA Ventura
Oxnard, California, 93030, United States
Stockton Hematology Oncology
Stockton, California, 95204, United States
Tahoe Forest Health System Cancer Center
Truckee, California, 96160, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Medical Oncology and Blood Disorders, LLP
Manchester, Connecticut, 06040, United States
Stamford Hospital
Stamford, Connecticut, 06904, United States
Washington Hospital Center, Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
George Washington University
Washington D.C., District of Columbia, 20237, United States
Hematology And Medical Oncology Of Southern Palm Beach County
Boynton Beach, Florida, 33435, United States
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
University Of Florida
Jacksonville, Florida, 32209, United States
Watson Clinic
Lakeland, Florida, 33805, United States
Central Florida Health Alliance
Leesburg, Florida, 34748, United States
Baptist Cancer Center
Miami, Florida, United States
Florida Cancer Specialists
New Port Richey, Florida, 34655, United States
Cancer Centers of Florida
Orlando, Florida, 32806, United States
Lake County Oncology and Hematology
Tavares, Florida, 32778, United States
Space Coast Cancer Center
Titusville, Florida, 32796, United States
Peachtree Hematology-Oncology
Atlanta, Georgia, 30318, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060, United States
Georgia Cancer Specialist
Sandy Springs, Georgia, 30342, United States
Lewis Hall Singeltary Oncology Center
Thomasville, Georgia, 31792, United States
OnCare
Honolulu, Hawaii, 96813, United States
Straub Clinical & Hospital
Honolulu, Hawaii, 96813, United States
Kaiser Permanente Honolulu
Honolulu, Hawaii, 96819, United States
Mahafzah Medical Center
Evergreen Park, Illinois, 60805, United States
Delnor Community Hospital
Geneva, Illinois, 60134, United States
Mid-Illinois Hem/Onc Asoc
Normal, Illinois, 61761, United States
North Chicago VA Medical Center
North Chicago, Illinois, 60064, United States
Southern Illinois School of Medicine
Springfield, Illinois, 62794, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Saint John's Cancer Center
Anderson, Indiana, 46016, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46260, United States
Horizon Oncology Research, Inc
Lafayette, Indiana, 47905, United States
Cancer Care Center, Inc. PC
New Albany, Indiana, 47150, United States
N. Iowa Mercy Cancer Center
Mason City, Iowa, 50401, United States
Hutchinson Clinic
Hutchinson, Kansas, 67502, United States
Cotton O'Neil Cancer Center
Topeka, Kansas, 66606, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
University of Louisville Hospital - Brown Cancer Center
Louisville, Kentucky, 40202, United States
Consultants In Blood Disorders
Saint Matthews, Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Willis-Knighton Cancer System
Shreveport, Louisiana, 71103, United States
Maryland Oncology Hematology Pa
Columbia, Maryland, 21044, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Sturdy Hematology & Oncology Associates
Attleboro, Massachusetts, 02703, United States
Boston VA Healthcare System
Boston, Massachusetts, 02130, United States
South Coast Health System
Fall River, Massachusetts, 02720, United States
Commonwealth Hematology-Oncology, P.C.
Quincy, Massachusetts, 02169, United States
UMass Medical Center
Worcester, Massachusetts, 01655, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Michigan State University
Lansing, Michigan, 48910, United States
North Mississippi Hematology & Oncology
Tupelo, Mississippi, 38801, United States
St John's Clinic for Cancer and Hematology
Springfield, Missouri, 65807, United States
Billings Clinic
Billings, Montana, 59101, United States
Omaha VAMC
Omaha, Nebraska, 68105, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Bms Clinical Research Center
Does Not Exist, New Jersey, 08690-3542, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, 07962, United States
Southern Oncology Hematology
Vineland, New Jersey, 08360, United States
Broome Oncology
Johnson City, New York, 13790, United States
Advanced Oncology
New York, New York, 10013, United States
St. Lukes Roosevelt Medical Center
New York, New York, 10019, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Montefiore Medical Center / AECOM
The Bronx, New York, 10467, United States
Alamance Regional Cancer Center
Burlington, North Carolina, 27215, United States
Waverly Hematology Oncology
Cary, North Carolina, 27518, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Gaston Hematology Oncology
Gastonia, North Carolina, 28054, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Medical Center of Newark
Newark, Ohio, 43055, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hematology/Oncology Salem LLP
Salem, Oregon, 97301, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704, United States
Lancaster General Health
Lancaster, Pennsylvania, 17601, United States
Veterans Research Foundation of Pittsburgh
Pittsburgh, Pennsylvania, 15240, United States
Berks Hematology-Oncology
West Reading, Pennsylvania, 19611, United States
Geisinger Health System
Wilkes-Barre, Pennsylvania, 18711, United States
Cancer Care Association Of York
York, Pennsylvania, 17403, United States
Hematology and Oncology Associates of RI
Cranston, Rhode Island, 02920, United States
The Cancer Center at Memorial Hospital
Pawtucket, Rhode Island, 02860, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Prairie Lakes Healthcare System, Inc
Watertown, South Dakota, 57201, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Texas Oncology
Amarillo, Texas, 79106, United States
Texas Oncology - Arlington South
Arlington, Texas, 76014, United States
Texas Oncology-Austin North
Austin, Texas, 78758, United States
Julie & Ben Rogers Cancer Institute
Beaumont, Texas, 77701, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230-2510, United States
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology-Methodist Charlton Cancer Center
Dallas, Texas, 75237, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Michael DeBakey VA Medical Center
Houston, Texas, 77030, United States
Texas Oncology
Lewisville, Texas, 75067, United States
Texas Oncology-McAllen South Second
McAllen, Texas, 78503, United States
Texas Oncology
Mesquite, Texas, 75150, United States
Texas Oncology-Midland Allison Cancer Center
Midland, Texas, 79701, United States
Texas Oncology-Odessa West Texas Cancer Center
Odessa, Texas, 79761, United States
Texas Oncology
Paris, Texas, 75460-5004, United States
North Texas Regional Cancer Center
Plano, Texas, 75075, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78217, United States
Texas Oncology
Waco, Texas, 76712, United States
Danville Hematology & Oncology
Danville, Virginia, 24541, United States
Hematology Oncology Associates of Fredricksburg
Fredericksburg, Virginia, 22408, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Swedish Cancer Institute-Eastside Hematology/Oncology
Bellevue, Washington, 98005, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99208, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
City Hospital - West Virginia University Hospital East
Martinsburg, West Virginia, 25401, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 53792, United States
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Offenbach, Germany
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Rostock, 18057, Germany
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Singen, 78224, Germany
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Soest, 59494, Germany
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Ulm, 89081, Germany
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Velbert, 42551, Germany
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Weiden, 92637, Germany
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Würzburg, 97080, Germany
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Brindisi, 72100, Italy
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Catania, 95124, Italy
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Florence, 50134, Italy
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Milan, 20122, Italy
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Milan, 20162, Italy
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Modena, 44100, Italy
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Monza, 20052, Italy
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Pavia, 27100, Italy
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Perugia, 06156, Italy
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Pesaro, 61122, Italy
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Rionero in Vulture, 85028, Italy
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Roma, 00189, Italy
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Rome, 00161, Italy
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Rome, 00168, Italy
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Siena, 53100, Italy
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Terni, 05100, Italy
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Udine, 33100, Italy
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Hoofddorp, 2134 TM, Netherlands
Puerto Rico Hematology Oncology Group
Bayamón, 00961, Puerto Rico
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Saint Petersburg, 197022, Russia
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Santiago de Compostela-A Coruña, Spain, 15706, Spain
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A Coruña, 15006, Spain
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Oviedo - Asturias, 33006, Spain
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Pamplona, 31008, Spain
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Salamanca, 37007, Spain
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Toledo, 45004, Spain
Related Publications (1)
Hehlmann R, Cortes JE, Zyczynski T, Gambacorti-Passerini C, Goldberg SL, Mauro MJ, Michallet M, Simonsson B, Williams LA, Gajavelli S, DeGutis I, Sen GP, Paquette RL. Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2019 Jan;94(1):46-54. doi: 10.1002/ajh.25306. Epub 2018 Oct 31.
PMID: 30290003DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 19, 2010
Study Start
December 2, 2010
Primary Completion
January 8, 2020
Study Completion
January 8, 2020
Last Updated
June 30, 2022
Record last verified: 2022-06