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Completed

NCT Number: NCT01244750

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

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Blois, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The rate of Complete Cytogenetic Response

    Time frame: 12 months

  2. The duration of initial TKI treatment

    Time frame: 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

    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)

  4. 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

  5. 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 outcomes

  1. 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).

  2. Non-hematologic side effects from treatment affecting patient quality of life and outcomes

    Time frame: Every 6 months

    Treatment discontinuations and changes

  3. Patient satisfaction with CML treatment

    Time frame: Every 6 months

    Cancer Therapy Satisfaction Questionnaire (CTSQ)

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study title

Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

Acronym: SIMPLICITY

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2010
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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