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Completed

NCT Number: NCT03045120

Determining Change in Cardiovascular and Metabolic Risks in Patients With Chronic Phase Chronic Myeloid Leukemia Receiving BCR-ABL Tyrosine Kinase Inhibitor First-Line Therapy in the United States

This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line TKIs in routine clinical practice in the US. All treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (SOC)/routine office visits. Additional research imaging will be performed and will be reviewed by core imaging laboratory. As the study is collecting data on management of CML, this study will not influence the prescribing or management practices at participating sites.

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Key information

Conditions

Chronic Phase 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

Mount Sinai Hospital, Chicago, Illinois, United States

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About this study

This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line TKIs in routine clinical practice in the US. All treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (SOC)/routine office visits. Additional research imaging will be performed and will be reviewed by core imaging laboratory. As the study is collecting data on management of CML, this study will not influence the prescribing or management practices at participating sites.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18 years at the time of Ph+ CP-CML diagnosis
  • Newly diagnosed chronic phase of Ph+ CP-CML, confirmed with cytogenetic and/or molecular testing at baseline
  • Treatment-naïve and initiating treatment with dasatinib, imatinib, nilotinib or bosutinib
  • Willingness and ability to comply with routine office visits

Exclusion criteria

  • Any other prior or active non-CML active malignancy for which the patient is receiving treatment
  • Participation in a therapeutic clinical trial for CML disease

Treatment and study plan

Primary outcomes

  1. changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score

    Time frame: up to 24 months

  2. changes in metabolic risk from baseline using metabolic lab values

    Time frame: up to 24 months

Secondary outcomes

  1. echocardiography to assess left ventricular function

    Time frame: up to 24 months

  2. urinary protein excretion to assess early vascular endothelial changes

    Time frame: up to 24 months

  3. coronary calcium scoring to assess coronary artery narrowing

    Time frame: up to 24 months

  4. metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease

    Time frame: up to 24 months

  5. safety and tolerability of first-line BCR-ABL TKIs in adults with CP-CML based on the number of treatment-related adverse events collected in the medical records

    Time frame: up to 24 months

  6. clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis

    Time frame: up to 24 months

  7. clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis

    Time frame: up to 24 months

  8. clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis

    Time frame: up to 24 months

  9. time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments

    Time frame: up to 24 months

  10. description of treatment patterns based on the number of changes in treatment dosing, interruptions, changes in therapy, duration of therapy and treatment discontinuations through the management of adverse events and comorbid disease

    Time frame: up to 24 months

  11. description of the demographic and clinical patient characteristics associated with initial treatment choice and changes of treatment based on the medical records

    Time frame: up to 24 months

  12. measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2017
Registry last updated
Dec 21, 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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