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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Myeloid Leukemia

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)

• Study Type: Observational
• Enrollment (Actual): 1494

Contacts and Locations

Study Locations

• France
  • 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
  • PRINGY cedex, France, 74374
    • Local Institution
  • Pierre Benite, France, 69495
    • Local Institution
• Germany
  • Amberg, Germany, 92224
    • Local Institution
  • Aschaffenburg, Germany
    • Local Institution
  • Baden-Baden, Germany
    • Local Institution
  • Bamberg, Germany, 96049
    • Local Institution
  • Berlin, Germany, 13353
    • Local Institution
  • Berlin, Germany, 12203
    • 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
    • Local Institution
• Italy
  • 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
  • Milan, Italy, 20122
    • Local Institution
  • Milano, Italy, 20162
    • 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, 00168
    • Local Institution
  • Rome, Italy, 00161
    • Local Institution
  • Siena, Italy, 53100
    • Local Institution
  • Terni, Italy, 05100
    • Local Institution
  • Udine, Italy, 33100
    • Local Institution
• Netherlands
  • Hoofddorp, Netherlands, 2134 TM
    • Local Institution
• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Puerto Rico Hematology Oncology Group
• Russian Federation
  • Saint-Petersburg, Russian Federation, 197022
    • Local Institution
• Spain
  • 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 Institution
  • Toledo, Spain, 45004
    • Local Insitution
• United States
  • Alabama
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
    • Sedona, Arizona, United States, 86336
      • Arizona Oncology Associates, Pc - Nahoa
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC - HOPE
  • Arkansas
    • Hot Springs National Park, Arkansas, United States, 71913
      • Genesis Cancer Center
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Hematology Oncology Associates
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center, Inc
    • Escondido, California, United States, 92025
      • Southwest Cancer Care Medical Group
    • Glendora, California, United States, 91741
      • Wilshire Oncology Medical Group, Inc
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Orange, California, United States, 92868
      • St. Joseph's Hospital
    • Oxnard, California, United States, 93030
      • PMK Medical Group, Inc. DBA Ventura
    • Stockton, California, United States, 95204
      • Stockton Hematology Oncology
    • Truckee, California, United States, 96160
      • Tahoe Forest Health System Cancer Center
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers
  • Connecticut
    • Manchester, Connecticut, United States, 06040
      • Medical Oncology and Blood Disorders, LLP
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center, Washington Cancer Institute
    • Washington, District of Columbia, United States, 20237
      • George Washington University
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Hematology And Medical Oncology Of Southern Palm Beach County
    • Fort Lauderdale, Florida, United States, 33308
      • Broward Oncology Associates
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute
    • Jacksonville, Florida, United States, 32209
      • University of Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
    • Lakeland, Florida, United States, 33805
      • Watson Clinic
    • Leesburg, Florida, United States, 34748
      • Central Florida Health Alliance
    • Miami, Florida, United States
      • Baptist Cancer Center
    • New Port Richey, Florida, United States, 34655
      • Florida Cancer Specialists
    • Orlando, Florida, United States, 32806
      • Cancer Centers of Florida
    • Tavares, Florida, United States, 32778
      • Lake County Oncology and Hematology
    • Titusville, Florida, United States, 32796
      • Space Coast Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30318
      • Peachtree Hematology-Oncology
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, PC
    • Sandy Springs, Georgia, United States, 30342
      • Georgia Cancer Specialist
    • Thomasville, Georgia, United States, 31792
      • Lewis Hall Singeltary Oncology Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Oncare
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinical & Hospital
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Honolulu
  • Illinois
    • Evergreen Park, Illinois, United States, 60805
      • Mahafzah Medical Center
    • Geneva, Illinois, United States, 60134
      • Delnor Community Hospital
    • Normal, Illinois, United States, 61761
      • Mid-Illinois Hem/Onc Asoc
    • North Chicago, Illinois, United States, 60064
      • North Chicago VA Medical Center
    • Springfield, Illinois, United States, 62794
      • Southern Illinois School of Medicine
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Indiana
    • Anderson, Indiana, United States, 46016
      • Saint John's Cancer Center
    • Indianapolis, Indiana, United States, 46260
      • Investigative Clinical Research of Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood and Marrow Transplantation
    • Lafayette, Indiana, United States, 47905
      • Horizon Oncology Research, Inc
    • New Albany, Indiana, United States, 47150
      • Cancer Care Center, Inc. PC
  • Iowa
    • Mason City, Iowa, United States, 50401
      • N. Iowa Mercy Cancer Center
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Hutchinson Clinic
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Cancer Center
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital - Brown Cancer Center
    • Saint Matthews, Kentucky, United States, 40207
      • Consultants in Blood Disorders
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Cancer System
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology PA
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital
  • Massachusetts
    • Attleboro, Massachusetts, United States, 02703
      • Sturdy Hematology & Oncology Associates
    • Boston, Massachusetts, United States, 02130
      • Boston VA Healthcare System
    • Fall River, Massachusetts, United States, 02720
      • South Coast Health System
    • Quincy, Massachusetts, United States, 02169
      • Commonwealth Hematology-Oncology, P.C.
    • Worcester, Massachusetts, United States, 01655
      • UMASS Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers of Western Michigan
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Lansing, Michigan, United States, 48910
      • Michigan State University
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Hematology & Oncology
  • Missouri
    • Springfield, Missouri, United States, 65807
      • St John's Clinic for Cancer and Hematology
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Omaha VAMC
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Portsmouth Regional Hospital
  • New Jersey
    • Does Not Exist, New Jersey, United States, 08690-3542
      • Bms Clinical Research Center
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07962
      • Hematology-Oncology Associates of Northern NJ, PA
    • Vineland, New Jersey, United States, 08360
      • Southern Oncology Hematology
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center / AECOM
    • Johnson City, New York, United States, 13790
      • Broome Oncology
    • New York, New York, United States, 10013
      • Advanced Oncology
    • New York, New York, United States, 10019
      • St. Lukes Roosevelt Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Alamance Regional Cancer Center
    • Cary, North Carolina, United States, 27518
      • Waverly Hematology Oncology
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Gastonia, North Carolina, United States, 28054
      • Gaston Hematology Oncology
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
    • Newark, Ohio, United States, 43055
      • Medical Center of Newark
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Cancer Care Associates
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Salem, Oregon, United States, 97301
      • Hematology/Oncology Salem LLP
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital and Health Network
    • Kingston, Pennsylvania, United States, 18704
      • Medical Oncology Associates of Wyoming Valley, PC
    • Lancaster, Pennsylvania, United States, 17601
      • Lancaster General Health
    • Pittsburgh, Pennsylvania, United States, 15240
      • Veterans Research Foundation of Pittsburgh
    • West Reading, Pennsylvania, United States, 19611
      • Berks Hematology-Oncology
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Health System
    • York, Pennsylvania, United States, 17403
      • Cancer Care Association of York
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Hematology and Oncology Associates of RI
    • Pawtucket, Rhode Island, United States, 02860
      • The Cancer Center at Memorial Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Research Institute
    • Watertown, South Dakota, United States, 57201
      • Prairie lakes Healthcare system, Inc
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Knoxville, Tennessee, United States, 37909
      • Tennessee Cancer Specialists
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Oncology
    • Arlington, Texas, United States, 76014
      • Texas Oncology - Arlington South
    • Austin, Texas, United States, 78758
      • Texas Oncology-Austin North
    • Beaumont, Texas, United States, 77701
      • Julie & Ben Rogers Cancer Institute
    • Dallas, Texas, United States, 75231
      • Texas Oncology-Dallas Presbyterian Hospital
    • Dallas, Texas, United States, 75237
      • Texas Oncology-Methodist Charlton Cancer Center
    • Dallas, Texas, United States, 75230-2510
      • Texas Oncology-Medical City Dallas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Michael Debakey VA Medical Center
    • Lewisville, Texas, United States, 75067
      • Texas Oncology
    • McAllen, Texas, United States, 78503
      • Texas Oncology-McAllen South Second
    • Mesquite, Texas, United States, 75150
      • Texas Oncology
    • Midland, Texas, United States, 79701
      • Texas Oncology-Midland Allison Cancer Center
    • Odessa, Texas, United States, 79761
      • Texas Oncology-Odessa West Texas Cancer Center
    • Paris, Texas, United States, 75460-5004
      • Texas Oncology
    • Plano, Texas, United States, 75075
      • North Texas Regional Cancer Center
    • San Antonio, Texas, United States, 78217
      • Cancer Care Centers of South Texas
    • Waco, Texas, United States, 76712
      • Texas Oncology
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Hematology & Oncology
    • Fredericksburg, Virginia, United States, 22408
      • Hematology Oncology Associates of Fredricksburg
    • Newport News, Virginia, United States, 23601
      • Peninsula Cancer Institute
    • Roanoke, Virginia, United States, 24014
      • Blue Ridge Cancer Care
  • Washington
    • Bellevue, Washington, United States, 98005
      • Swedish Cancer Institute-Eastside Hematology/Oncology
    • Spokane, Washington, United States, 99208
      • Providence Cancer Center at Sacred Heart Medical Center
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital/North Star Lodge
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center
    • Martinsburg, West Virginia, United States, 25401
      • City Hospital - West Virginia University Hospital East
    • Wheeling, West Virginia, United States, 26003
      • Wheeling Hospital
  • Wisconsin
    • Wausau, Wisconsin, United States, 53792
      • Aspirus Regional Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of first-line treatment options on quality of life	Questionnaires used for assessment: Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).	Every 6 months
Non-hematologic side effects from treatment affecting patient quality of life and outcomes	Treatment discontinuations and changes	Every 6 months
Patient satisfaction with CML treatment	Cancer Therapy Satisfaction Questionnaire (CTSQ)	Every 6 months
Patterns of disease monitoring as observed in a real-world setting	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	Every 6 months
Resource utilization associated with CML management	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.	Every 6 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: ICON Clinical Research

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA Safety Alerts and Recalls
• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2010
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Phase - Chronic Myeloid Leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: CA180-330