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.
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
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Phase Chronic Myeloid Leukemia
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03045120
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA180-653
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score
Outcome Time Frame
up to 24 months
Outcome Measure
changes in metabolic risk from baseline using metabolic lab values
Outcome Time Frame
up to 24 months
Secondary Outcomes
Outcome Time Frame
up to 24 months
Outcome Measure
echocardiography to assess left ventricular function
Outcome Time Frame
up to 24 months
Outcome Measure
urinary protein excretion to assess early vascular endothelial changes
Outcome Time Frame
up to 24 months
Outcome Measure
coronary calcium scoring to assess coronary artery narrowing
Outcome Time Frame
up to 24 months
Outcome Measure
metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease
Outcome Time Frame
up to 24 months
Outcome Measure
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
Outcome Time Frame
up to 24 months
Outcome Measure
clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis
Outcome Time Frame
up to 24 months
Outcome Measure
clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis
Outcome Time Frame
up to 24 months
Outcome Measure
clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis
Outcome Time Frame
up to 24 months
Outcome Measure
time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments
Outcome Time Frame
up to 24 months
Outcome Measure
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
Outcome Time Frame
up to 24 months
Outcome Measure
description of the demographic and clinical patient characteristics associated with initial treatment choice and changes of treatment based on the medical records
Outcome Time Frame
up to 24 months
Outcome Measure
measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ioannis Mantzaris
Investigator Email
IMANTZAR@montefiore.org
Investigator Phone