Clinical trial NCT01244750: Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
Official title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic Phase - Chronic Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2010-11-19
Enrollment: 1494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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 criteria: 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

Primary outcomes:
measure: The rate of Complete Cytogenetic Response
timeFrame: 12 months
measure: The duration of initial TKI treatment
timeFrame: 5-years from study index date
measure: The rate of discontinuation and treatment changes after initial TKI treatment
timeFrame: Every 6 months for a follow-up period of 5-years from study index date
measure: The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)
timeFrame: Every 6 months for a follow-up period of 5-years from study index date
measure: The adherence to treatment
timeFrame: Every 6 months for a follow-up period of 5-years from study index date
Secondary outcomes:
measure: Impact of first-line treatment options on quality of life
timeFrame: Every 6 months
measure: Non-hematologic side effects from treatment affecting patient quality of life and outcomes
timeFrame: Every 6 months
measure: Patient satisfaction with CML treatment
timeFrame: Every 6 months
measure: Patterns of disease monitoring as observed in a real-world setting
timeFrame: Every 6 months
measure: Resource utilization associated with CML management
timeFrame: Every 6 months
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Sedona
country: United States
facility: Arizona Oncology Associates, PC - NAHOA
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Hot Springs National Park
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology Associates
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc
state: California
city: Escondido
country: United States
facility: Southwest Cancer Care Medical Group
state: California
city: Glendora
country: United States
facility: Wilshire Oncology Medical Group, Inc
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Orange
country: United States
facility: St. Joseph's Hospital
state: California
city: Oxnard
country: United States
facility: PMK Medical Group, Inc. DBA Ventura
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology
state: California
city: Truckee
country: United States
facility: Tahoe Forest Health System Cancer Center
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Manchester
country: United States
facility: Medical Oncology and Blood Disorders, LLP
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center, Washington Cancer Institute
state: District of Columbia
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Boynton Beach
country: United States
facility: Hematology And Medical Oncology Of Southern Palm Beach County
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: University Of Florida
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic
state: Florida
city: Leesburg
country: United States
facility: Central Florida Health Alliance
state: Florida
city: Miami
country: United States
facility: Baptist Cancer Center
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Tavares
country: United States
facility: Lake County Oncology and Hematology
state: Florida
city: Titusville
country: United States
facility: Space Coast Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology-Oncology
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Sandy Springs
country: United States
facility: Georgia Cancer Specialist
state: Georgia
city: Thomasville
country: United States
facility: Lewis Hall Singeltary Oncology Center
state: Georgia
city: Honolulu
country: United States
facility: OnCare
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinical & Hospital
state: Hawaii
city: Honolulu
country: United States
facility: Kaiser Permanente Honolulu
state: Hawaii
city: Evergreen Park
country: United States
facility: Mahafzah Medical Center
state: Illinois
city: Geneva
country: United States
facility: Delnor Community Hospital
state: Illinois
city: Normal
country: United States
facility: Mid-Illinois Hem/Onc Asoc
state: Illinois
city: North Chicago
country: United States
facility: North Chicago VA Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois School of Medicine
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Anderson
country: United States
facility: Saint John's Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center, Inc. PC
state: Indiana
city: Mason City
country: United States
facility: N. Iowa Mercy Cancer Center
state: Iowa
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Cancer Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital - Brown Cancer Center
state: Kentucky
city: Saint Matthews
country: United States
facility: Consultants In Blood Disorders
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Cancer System
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology Pa
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Attleboro
country: United States
facility: Sturdy Hematology & Oncology Associates
state: Massachusetts
city: Boston
country: United States
facility: Boston VA Healthcare System
state: Massachusetts
city: Fall River
country: United States
facility: South Coast Health System
state: Massachusetts
city: Quincy
country: United States
facility: Commonwealth Hematology-Oncology, P.C.
state: Massachusetts
city: Worcester
country: United States
facility: UMass Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Hematology & Oncology
state: Mississippi
city: Springfield
country: United States
facility: St John's Clinic for Cancer and Hematology
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Omaha
country: United States
facility: Omaha VAMC
state: Nebraska
city: Portsmouth
country: United States
facility: Portsmouth Regional Hospital
state: New Hampshire
city: Does Not Exist
country: United States
facility: Bms Clinical Research Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of Northern NJ, PA
state: New Jersey
city: Vineland
country: United States
facility: Southern Oncology Hematology
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center / AECOM
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: New York
country: United States
facility: Advanced Oncology
state: New York
city: New York
country: United States
facility: St. Lukes Roosevelt Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Burlington
country: United States
facility: Alamance Regional Cancer Center
state: North Carolina
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Hematology Oncology
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Newark
country: United States
facility: Medical Center of Newark
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Salem
country: United States
facility: Hematology/Oncology Salem LLP
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyoming Valley, PC
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Research Foundation of Pittsburgh
state: Pennsylvania
city: West Reading
country: United States
facility: Berks Hematology-Oncology
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Association Of York
state: Pennsylvania
city: Cranston
country: United States
facility: Hematology and Oncology Associates of RI
state: Rhode Island
city: Pawtucket
country: United States
facility: The Cancer Center at Memorial Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Watertown
country: United States
facility: Prairie Lakes Healthcare System, Inc
state: South Dakota
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology
state: Texas
city: Arlington
country: United States
facility: Texas Oncology - Arlington South
state: Texas
city: Austin
country: United States
facility: Texas Oncology-Austin North
state: Texas
city: Beaumont
country: United States
facility: Julie & Ben Rogers Cancer Institute
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Methodist Charlton Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Michael DeBakey VA Medical Center
state: Texas
city: Lewisville
country: United States
facility: Texas Oncology
state: Texas
city: McAllen
country: United States
facility: Texas Oncology-McAllen South Second
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology
state: Texas
city: Midland
country: United States
facility: Texas Oncology-Midland Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: Texas Oncology-Odessa West Texas Cancer Center
state: Texas
city: Paris
country: United States
facility: Texas Oncology
state: Texas
city: Plano
country: United States
facility: North Texas Regional Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Waco
country: United States
facility: Texas Oncology
state: Texas
city: Danville
country: United States
facility: Danville Hematology & Oncology
state: Virginia
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredricksburg
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Bellevue
country: United States
facility: Swedish Cancer Institute-Eastside Hematology/Oncology
state: Washington
city: Spokane
country: United States
facility: Providence Cancer Center at Sacred Heart Medical Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Martinsburg
country: United States
facility: City Hospital - West Virginia University Hospital East
state: West Virginia
city: Wheeling
country: United States
facility: Wheeling Hospital
state: West Virginia
city: Wausau
country: United States
facility: Aspirus Regional Cancer Center
state: Wisconsin
city: Blois cedex
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Chalon/Saone Cedex
country: France
facility: Local Institution
city: Chambéry
country: France
facility: Local Institution
city: Le Mans Cedex 09
country: France
facility: Local Institution
city: Pierre Benite
country: France
facility: Local Institution
city: PRINGY cedex
country: France
facility: Local Institution
city: Amberg
country: Germany
facility: Local Institution
city: Aschaffenburg
country: Germany
facility: Local Institution
city: Baden-Baden
country: Germany
facility: Local Institution
city: Bamberg
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Bottrop
country: Germany
facility: Local Institution
city: Coburg
country: Germany
facility: Local Institution
city: Darmstadt
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt am Main
country: Germany
facility: Local Institution
city: Frankurt am Main
country: Germany
facility: Local Institution
city: Greifswald
country: Germany
facility: Local Institution
city: Hamm
country: Germany
facility: Local Institution
city: Hof
country: Germany
facility: Local Institution
city: Idar-Oberstein
country: Germany
facility: Local Institution
city: Kaiserslautern
country: Germany
facility: Local Institution
city: Kassel
country: Germany
facility: Local Institution
city: Koblenz
country: Germany
facility: Local Institution
city: Köln
country: Germany
facility: Local Institution
city: Köln
country: Germany
facility: Local Institution
city: Landshut
country: Germany
facility: Local Institution
city: Lebach
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Mülheim A. D. Ruhr
country: Germany
facility: Local Institution
city: Offenbach
country: Germany
facility: Local Institution
city: Potsdam
country: Germany
facility: Local Institution
city: Rostock
country: Germany
facility: Local Institution
city: Rötha
country: Germany
facility: Local Institution
city: Singen
country: Germany
facility: Local Institution
city: Soest
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Velbert
country: Germany
facility: Local Institution
city: Weiden
country: Germany
facility: Local Institution
city: Würzburg
country: Germany
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Brindisi
country: Italy
facility: Local Institution
city: Catania
country: Italy
facility: Local Institution
city: Florence
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Monza
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: Pesaro
country: Italy
facility: Local Institution
city: Rionero in Vulture
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: Rome
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Terni
country: Italy
facility: Local Institution
city: Udine
country: Italy
facility: Local Institution
city: Hoofddorp
country: Netherlands
facility: Local Institution
city: Bayamon
country: Puerto Rico
facility: Puerto Rico Hematology Oncology Group
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: La Coruña
country: Spain
facility: Local Institution
city: Oviedo - Asturias
country: Spain
facility: Local Institution
city: Pamplona
country: Spain
facility: Local Institution
city: Salamanca
country: Spain
facility: Local Institution
city: Santiago De Compostela-A Coruña
country: Spain
facility: Local Institution
city: Toledo
country: Spain
facility: Local Insitution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.