Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01244750
Collaborator
ICON Clinical Research (Industry)
1,494
Enrollment
214
Locations
109.2
Actual Duration (Months)
7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase

    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 Design

    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 :
    Dec 2, 2010
    Actual Primary Completion Date :
    Jan 8, 2020
    Actual Study Completion Date :
    Jan 8, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. The rate of Complete Cytogenetic Response [12 months]

    2. The duration of initial TKI treatment [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 [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) [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 [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 [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 [Every 6 months]

      Treatment discontinuations and changes

    3. Patient satisfaction with CML treatment [Every 6 months]

      Cancer Therapy Satisfaction Questionnaire (CTSQ)

    4. Patterns of disease monitoring as observed in a real-world setting [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    1. Dasatinib Cohort
    • Patients who started their first-line Dasatinib treatment after the drug was approved in this indication
    1. 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

    Locations

    Site City State Country Postal Code
    1 Northwest Alabama Cancer Center Muscle Shoals Alabama United States 35661
    2 Arizona Oncology Associates, PC - HAL Phoenix Arizona United States 85016
    3 Arizona Oncology Associates, PC - NAHOA Sedona Arizona United States 86336
    4 Arizona Oncology Associates, PC - HOPE Tucson Arizona United States 85704
    5 Genesis Cancer Center Hot Springs National Park Arkansas United States 71913
    6 NEA Baptist Clinic Jonesboro Arkansas United States 72401
    7 Little Rock Hematology Oncology Associates Little Rock Arkansas United States 72205
    8 Pacific Cancer Medical Center, Inc Anaheim California United States 92801
    9 Southwest Cancer Care Medical Group Escondido California United States 92025
    10 Wilshire Oncology Medical Group, Inc Glendora California United States 91741
    11 University of Southern California Los Angeles California United States 90033
    12 St. Joseph's Hospital Orange California United States 92868
    13 PMK Medical Group, Inc. DBA Ventura Oxnard California United States 93030
    14 Stockton Hematology Oncology Stockton California United States 95204
    15 Tahoe Forest Health System Cancer Center Truckee California United States 96160
    16 Rocky Mountain Cancer Centers Boulder Colorado United States 80303
    17 Medical Oncology and Blood Disorders, LLP Manchester Connecticut United States 06040
    18 Stamford Hospital Stamford Connecticut United States 06904
    19 Washington Hospital Center, Washington Cancer Institute Washington District of Columbia United States 20010
    20 George Washington University Washington District of Columbia United States 20237
    21 Hematology And Medical Oncology Of Southern Palm Beach County Boynton Beach Florida United States 33435
    22 Broward Oncology Associates Fort Lauderdale Florida United States 33308
    23 Palm Springs Research Institute Hialeah Florida United States 33012
    24 Baptist Cancer Institute Jacksonville Florida United States 32207
    25 University Of Florida Jacksonville Florida United States 32209
    26 Watson Clinic Lakeland Florida United States 33805
    27 Central Florida Health Alliance Leesburg Florida United States 34748
    28 Baptist Cancer Center Miami Florida United States
    29 Florida Cancer Specialists New Port Richey Florida United States 34655
    30 Cancer Centers of Florida Orlando Florida United States 32806
    31 Lake County Oncology and Hematology Tavares Florida United States 32778
    32 Space Coast Cancer Center Titusville Florida United States 32796
    33 Peachtree Hematology-Oncology Atlanta Georgia United States 30318
    34 Emory University Atlanta Georgia United States 30322
    35 Northwest Georgia Oncology Centers, PC Marietta Georgia United States 30060
    36 Georgia Cancer Specialist Sandy Springs Georgia United States 30342
    37 Lewis Hall Singeltary Oncology Center Thomasville Georgia United States 31792
    38 OnCare Honolulu Hawaii United States 96813
    39 Straub Clinical & Hospital Honolulu Hawaii United States 96813
    40 Kaiser Permanente Honolulu Honolulu Hawaii United States 96819
    41 Mahafzah Medical Center Evergreen Park Illinois United States 60805
    42 Delnor Community Hospital Geneva Illinois United States 60134
    43 Mid-Illinois Hem/Onc Asoc Normal Illinois United States 61761
    44 North Chicago VA Medical Center North Chicago Illinois United States 60064
    45 Southern Illinois School of Medicine Springfield Illinois United States 62794
    46 Carle Cancer Center Urbana Illinois United States 61801
    47 Central DuPage Hospital Winfield Illinois United States 60190
    48 Saint John's Cancer Center Anderson Indiana United States 46016
    49 Indiana Blood and Marrow Transplantation Indianapolis Indiana United States 46237
    50 Investigative Clinical Research of Indiana Indianapolis Indiana United States 46260
    51 Horizon Oncology Research, Inc Lafayette Indiana United States 47905
    52 Cancer Care Center, Inc. PC New Albany Indiana United States 47150
    53 N. Iowa Mercy Cancer Center Mason City Iowa United States 50401
    54 Hutchinson Clinic Hutchinson Kansas United States 67502
    55 Cotton O'Neil Cancer Center Topeka Kansas United States 66606
    56 Cancer Center of Kansas Wichita Kansas United States 67214
    57 Central Baptist Hospital Lexington Kentucky United States 40503
    58 University of Louisville Hospital - Brown Cancer Center Louisville Kentucky United States 40202
    59 Consultants In Blood Disorders Saint Matthews Kentucky United States 40207
    60 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    61 Willis-Knighton Cancer System Shreveport Louisiana United States 71103
    62 Maryland Oncology Hematology Pa Columbia Maryland United States 21044
    63 Frederick Memorial Hospital Frederick Maryland United States 21701
    64 Sturdy Hematology & Oncology Associates Attleboro Massachusetts United States 02703
    65 Boston VA Healthcare System Boston Massachusetts United States 02130
    66 South Coast Health System Fall River Massachusetts United States 02720
    67 Commonwealth Hematology-Oncology, P.C. Quincy Massachusetts United States 02169
    68 UMass Medical Center Worcester Massachusetts United States 01655
    69 Cancer & Hematology Centers of Western Michigan Grand Rapids Michigan United States 49503
    70 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    71 Michigan State University Lansing Michigan United States 48910
    72 North Mississippi Hematology & Oncology Tupelo Mississippi United States 38801
    73 St John's Clinic for Cancer and Hematology Springfield Missouri United States 65807
    74 Billings Clinic Billings Montana United States 59101
    75 Omaha VAMC Omaha Nebraska United States 68105
    76 Portsmouth Regional Hospital Portsmouth New Hampshire United States 03801
    77 Bms Clinical Research Center Does Not Exist New Jersey United States 08690-3542
    78 Hackensack University Medical Center Hackensack New Jersey United States 07601
    79 Hematology-Oncology Associates of Northern NJ, PA Morristown New Jersey United States 07962
    80 Southern Oncology Hematology Vineland New Jersey United States 08360
    81 Montefiore Medical Center / AECOM Bronx New York United States 10467
    82 Broome Oncology Johnson City New York United States 13790
    83 Advanced Oncology New York New York United States 10013
    84 St. Lukes Roosevelt Medical Center New York New York United States 10019
    85 Vassar Brothers Medical Center Poughkeepsie New York United States 12601
    86 Stony Brook University Hospital Stony Brook New York United States 11794
    87 Alamance Regional Cancer Center Burlington North Carolina United States 27215
    88 Waverly Hematology Oncology Cary North Carolina United States 27518
    89 Duke University Medical Center Durham North Carolina United States 27710
    90 Gaston Hematology Oncology Gastonia North Carolina United States 28054
    91 East Carolina University Greenville North Carolina United States 27834
    92 Akron General Medical Center Akron Ohio United States 44302
    93 Gabrail Cancer Center Canton Ohio United States 44718
    94 Signal Point Clinical Research Center, LLC Middletown Ohio United States 45042
    95 Medical Center of Newark Newark Ohio United States 43055
    96 Cancer Care Associates Tulsa Oklahoma United States 74136
    97 Oregon Health & Science University Portland Oregon United States 97239
    98 Hematology/Oncology Salem LLP Salem Oregon United States 97301
    99 Lehigh Valley Hospital Allentown Pennsylvania United States 18103
    100 St. Luke's Hospital and Health Network Bethlehem Pennsylvania United States 18015
    101 Medical Oncology Associates of Wyoming Valley, PC Kingston Pennsylvania United States 18704
    102 Lancaster General Health Lancaster Pennsylvania United States 17601
    103 Veterans Research Foundation of Pittsburgh Pittsburgh Pennsylvania United States 15240
    104 Berks Hematology-Oncology West Reading Pennsylvania United States 19611
    105 Geisinger Health System Wilkes-Barre Pennsylvania United States 18711
    106 Cancer Care Association Of York York Pennsylvania United States 17403
    107 Hematology and Oncology Associates of RI Cranston Rhode Island United States 02920
    108 The Cancer Center at Memorial Hospital Pawtucket Rhode Island United States 02860
    109 Charleston Cancer Center Charleston South Carolina United States 29406
    110 Avera Research Institute Sioux Falls South Dakota United States 57105
    111 Prairie Lakes Healthcare System, Inc Watertown South Dakota United States 57201
    112 Tennessee Cancer Specialists Knoxville Tennessee United States 37909
    113 University of Tennessee Medical Center Knoxville Tennessee United States 37920
    114 Texas Oncology Amarillo Texas United States 79106
    115 Texas Oncology - Arlington South Arlington Texas United States 76014
    116 Texas Oncology-Austin North Austin Texas United States 78758
    117 Julie & Ben Rogers Cancer Institute Beaumont Texas United States 77701
    118 Texas Oncology-Medical City Dallas Dallas Texas United States 75230-2510
    119 Texas Oncology-Dallas Presbyterian Hospital Dallas Texas United States 75231
    120 Texas Oncology-Methodist Charlton Cancer Center Dallas Texas United States 75237
    121 MD Anderson Cancer Center Houston Texas United States 77030
    122 Michael DeBakey VA Medical Center Houston Texas United States 77030
    123 Texas Oncology Lewisville Texas United States 75067
    124 Texas Oncology-McAllen South Second McAllen Texas United States 78503
    125 Texas Oncology Mesquite Texas United States 75150
    126 Texas Oncology-Midland Allison Cancer Center Midland Texas United States 79701
    127 Texas Oncology-Odessa West Texas Cancer Center Odessa Texas United States 79761
    128 Texas Oncology Paris Texas United States 75460-5004
    129 North Texas Regional Cancer Center Plano Texas United States 75075
    130 Cancer Care Centers of South Texas San Antonio Texas United States 78217
    131 Texas Oncology Waco Texas United States 76712
    132 Danville Hematology & Oncology Danville Virginia United States 24541
    133 Hematology Oncology Associates of Fredricksburg Fredericksburg Virginia United States 22408
    134 Peninsula Cancer Institute Newport News Virginia United States 23601
    135 Blue Ridge Cancer Care Roanoke Virginia United States 24014
    136 Swedish Cancer Institute-Eastside Hematology/Oncology Bellevue Washington United States 98005
    137 Providence Cancer Center at Sacred Heart Medical Center Spokane Washington United States 99208
    138 Wenatchee Valley Medical Center Wenatchee Washington United States 98801
    139 Yakima Valley Memorial Hospital/North Star Lodge Yakima Washington United States 98902
    140 Charleston Area Medical Center Charleston West Virginia United States 25304
    141 City Hospital - West Virginia University Hospital East Martinsburg West Virginia United States 25401
    142 Wheeling Hospital Wheeling West Virginia United States 26003
    143 Aspirus Regional Cancer Center Wausau Wisconsin United States 53792
    144 Local Institution Blois cedex France 41016
    145 Local Institution Bordeaux France 33300
    146 Local Institution Chalon/Saone Cedex France 71100
    147 Local Institution Chambéry France 73011
    148 Local Institution Le Mans Cedex 09 France 72037
    149 Local Institution Pierre Benite France 69495
    150 Local Institution PRINGY cedex France 74374
    151 Local Institution Amberg Germany 92224
    152 Local Institution Aschaffenburg Germany
    153 Local Institution Baden-Baden Germany
    154 Local Institution Bamberg Germany 96049
    155 Local Institution Berlin Germany 12203
    156 Local Institution Berlin Germany 13353
    157 Local Institution Bonn Germany 53105
    158 Local Institution Bottrop Germany 46236
    159 Local Institution Coburg Germany 96450
    160 Local Institution Darmstadt Germany 64283
    161 Local Institution Essen Germany 45136
    162 Local Institution Frankfurt am Main Germany
    163 Local Institution Frankurt am Main Germany 60389
    164 Local Institution Greifswald Germany 17475
    165 Local Institution Hamm Germany 59063
    166 Local Institution Hof Germany 95028
    167 Local Institution Idar-Oberstein Germany 55743
    168 Local Institution Kaiserslautern Germany
    169 Local Institution Kassel Germany 34117
    170 Local Institution Koblenz Germany 56068
    171 Local Institution Köln Germany 50674
    172 Local Institution Köln Germany 50677
    173 Local Institution Landshut Germany 84028
    174 Local Institution Lebach Germany 66822
    175 Local Institution Leipzig Germany 04103
    176 Local Institution Mülheim A. D. Ruhr Germany 45468
    177 Local Institution Offenbach Germany
    178 Local Institution Potsdam Germany 14467
    179 Local Institution Rostock Germany 18057
    180 Local Institution Rötha Germany 04571
    181 Local Institution Singen Germany 78224
    182 Local Institution Soest Germany 59494
    183 Local Institution Ulm Germany 89081
    184 Local Institution Velbert Germany 42551
    185 Local Institution Weiden Germany 92637
    186 Local Institution Würzburg Germany 97080
    187 Local Institution Bari Italy 70124
    188 Local Institution Brescia Italy 25123
    189 Local Institution Brindisi Italy 72100
    190 Local Institution Catania Italy 95124
    191 Local Institution Florence Italy 50134
    192 Local Institution Milano Italy 20162
    193 Local Institution Milan Italy 20122
    194 Local Institution Modena Italy 44100
    195 Local Institution Monza Italy 20052
    196 Local Institution Pavia Italy 27100
    197 Local Institution Perugia Italy 06156
    198 Local Institution Pesaro Italy 61122
    199 Local Institution Rionero in Vulture Italy 85028
    200 Local Institution Roma Italy 00189
    201 Local Institution Rome Italy 00161
    202 Local Institution Rome Italy 00168
    203 Local Institution Siena Italy 53100
    204 Local Institution Terni Italy 05100
    205 Local Institution Udine Italy 33100
    206 Local Institution Hoofddorp Netherlands 2134 TM
    207 Puerto Rico Hematology Oncology Group Bayamon Puerto Rico 00961
    208 Local Institution Saint-Petersburg Russian Federation 197022
    209 Local Institution La Coruña Spain 15006
    210 Local Institution Oviedo - Asturias Spain 33006
    211 Local Institution Pamplona Spain 31008
    212 Local Institution Salamanca Spain 37007
    213 Local Institution Santiago De Compostela-A Coruña Spain 15706
    214 Local Insitution Toledo Spain 45004

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • ICON Clinical Research

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01244750
    Other Study ID Numbers:
    • CA180-330
    First Posted:
    Nov 19, 2010
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Bristol-Myers Squibb
    Chronic Phase - Chronic Myeloid Leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive

    Study Results

    No Results Posted as of Jun 30, 2022