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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

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ClinicalTrials.gov Identifier: NCT03045120
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date January 31, 2017
First Posted Date February 7, 2017
Last Update Posted Date April 30, 2020
Actual Study Start Date March 29, 2017
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2017)
  • 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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2017)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Therapy in the United States
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 Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
biomarker analyses will be collected for metabolic panels
Sampling Method Probability Sample
Study Population Newly-diagnosed, treatment-naïve CP-CML patients who are ≥ 18 years at the time of CP-CML diagnosis who are scheduled to initiate treatment with dasatinib, imatinib, nilotinib or Bosutinib are eligible for enrollment. Enrolled patients (n=200) will be distributed across the 3 patient treatment groups of newly diagnosed CP-CML patients who will initiate their first- line TKI treatment.
Condition Chronic Phase Chronic Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts
  • dasatinib cohort
    Intended to characterize the impact of dasatinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
  • imatinib cohort
    Intended to characterize the impact of imatinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
  • nilotinib cohort
    Intended to characterize the impact of nilotinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
  • bosutinib cohort
    Intended to characterize the impact of bosutinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 3, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. ≥ 18 years at the time of Ph+ CP-CML diagnosis
  2. Newly diagnosed chronic phase of Ph+ CP-CML, confirmed with cytogenetic and/or molecular testing at baseline
  3. Treatment-naïve and initiating treatment with dasatinib, imatinib, nilotinib or bosutinib
  4. Willingness and ability to comply with routine office visits

Exclusion Criteria:

  1. Any other prior or active non-CML active malignancy for which the patient is receiving treatment
  2. Participation in a therapeutic clinical trial for CML disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03045120
Other Study ID Numbers CA180-653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Not Provided
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2020