Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Determining Change in Cardiovascular and Metabolic Risks in Patients With Chronic Phase Chronic Myeloid Leukemia Receiving BCR-ABL Tyrosine Kinase Inhibitor First-Line The

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Bristol-Myers Squibb

Current Primary Outcome:

  • changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score [ Time Frame: up to 24 months ]
  • changes in metabolic risk from baseline using metabolic lab values [ Time Frame: up to 24 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • echocardiography to assess left ventricular function [ Time Frame: up to 24 months ]
  • urinary protein excretion to assess early vascular endothelial changes [ Time Frame: up to 24 months ]
  • coronary calcium scoring to assess coronary artery narrowing [ Time Frame: up to 24 months ]
  • metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease [ Time Frame: up to 24 months ]
  • 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 ]
  • clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
  • clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
  • clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
  • time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments [ Time Frame: up to 24 months ]
  • 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 ]
  • 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 ]
  • measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease [ Time Frame: up to 24 months ]


Original Secondary Outcome: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: January 31, 2017
Date Started: February 2017
Date Completion: July 2021
Last Updated: February 3, 2017
Last Verified: February 2017