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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:
ClinicalTrials.gov Identifier:
NCT01244750
First Posted: November 19, 2010
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention
Chronic Myeloid Leukemia Other: Non-Interventional

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1494
Actual Study Start Date: December 2, 2010
Estimated Study Completion Date: August 30, 2020
Estimated Primary Completion Date: January 30, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
First line TKI treatment: Imatinib
Diagnosed CML patients who receive first line TKI treatment: Imatinib
Other: Non-Interventional
Non-Interventional
First line TKI treatment: Nilotinib
Diagnosed CML patients who receive first line TKI treatment: Nilotinib
Other: Non-Interventional
Non-Interventional
First line TKI treatment: Dasatinib
Diagnosed CML patients who receive first line TKI treatment: Dasatinib
Other: Non-Interventional
Non-Interventional
Imatinib treated patients
Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010
Other: Non-Interventional
Non-Interventional

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244750


  Show 214 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
ICON Clinical Research
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01244750     History of Changes
Other Study ID Numbers: CA180-330
First Submitted: November 15, 2010
First Posted: November 19, 2010
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by Bristol-Myers Squibb:
Chronic Phase - Chronic Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action