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

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ClinicalTrials.gov Identifier: NCT01244750
Recruitment Status : Unknown
Verified January 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2010
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date November 15, 2010
First Posted Date November 19, 2010
Last Update Posted Date January 23, 2018
Actual Study Start Date December 2, 2010
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2011)
  • The rate of Complete Cytogenetic Response [ Time Frame: 12 months ]
  • The duration of initial TKI treatment [ Time Frame: 5-years from study index date ]
    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 ]
    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 ]
    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 ]
    Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
Original Primary Outcome Measures
 (submitted: November 18, 2010)
  • The rate of Complete Cytogenetic Response [ Time Frame: 12 months ]
  • The duration of initial TKI treatment [ Time Frame: 5-years from study index date ]
    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 ]
    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 ]
    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 ]
    Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
Change History
Current Secondary Outcome Measures
 (submitted: December 3, 2010)
  • Impact of first-line treatment options on quality of life [ Time Frame: 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).
  • Non-hematologic side effects from treatment affecting patient quality of life and outcomes [ Time Frame: Every 6 months ]
    Treatment discontinuations and changes
  • Patient satisfaction with CML treatment [ Time Frame: Every 6 months ]
    Cancer Therapy Satisfaction Questionnaire (CTSQ)
  • Patterns of disease monitoring as observed in a real-world setting [ Time Frame: 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
  • Resource utilization associated with CML management [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: November 18, 2010)
  • Impact of first-line treatment options on quality of life [ Time Frame: 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).
  • Non-hematologic side effects from treatment affecting patient quality of life and outcomes [ Time Frame: Every 6 months ]
    Treatment discontinuations and changes
  • Patient satisfaction with CML treatment [ Time Frame: Every 6 months ]
    Cancer Therapy Satisfaction Questionnaire (CTSQ)
  • Patterns of disease monitoring as observed in a real-world setting [ Time Frame: 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
  • Resource utilization associated with CML management [ Time Frame: Every 6 months ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Chronic Myeloid Leukemia
Intervention Other: Non-Interventional
Non-Interventional
Study Groups/Cohorts
  • First line TKI treatment: Imatinib
    Diagnosed CML patients who receive first line TKI treatment: Imatinib
    Intervention: Other: Non-Interventional
  • First line TKI treatment: Nilotinib
    Diagnosed CML patients who receive first line TKI treatment: Nilotinib
    Intervention: Other: Non-Interventional
  • First line TKI treatment: Dasatinib
    Diagnosed CML patients who receive first line TKI treatment: Dasatinib
    Intervention: Other: Non-Interventional
  • Imatinib treated patients
    Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010
    Intervention: Other: Non-Interventional
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: March 18, 2016)
1494
Original Estimated Enrollment
 (submitted: November 18, 2010)
1400
Estimated Study Completion Date August 30, 2020
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Italy,   Netherlands,   Puerto Rico,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01244750
Other Study ID Numbers CA180-330
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators ICON Clinical Research
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date January 2018