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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

November 15, 2010
March 18, 2016
December 2010
January 2018   (final data collection date for primary outcome measure)
  • 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.
  • 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, PCR, 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.
Complete list of historical versions of study NCT01244750 on ClinicalTrials.gov Archive Site
  • 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.
  • 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-word disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.
Not Provided
Not Provided
 
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
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.
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)
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample
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
Chronic Myeloid Leukemia
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1494
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Netherlands,   Puerto Rico,   Russian Federation,   Spain
 
NCT01244750
CA180-330
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
ICON Clinical Research
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP