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
- Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Registration Number
- NCT03045120
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- ≥ 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score up to 24 months changes in metabolic risk from baseline using metabolic lab values up to 24 months
- Secondary Outcome Measures
Name Time Method echocardiography to assess left ventricular function up to 24 months urinary protein excretion to assess early vascular endothelial changes up to 24 months coronary calcium scoring to assess coronary artery narrowing up to 24 months metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease 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 up to 24 months clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis up to 24 months clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis up to 24 months clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis up to 24 months time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments 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 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 up to 24 months measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease up to 24 months
Trial Locations
- Locations (23)
Mount Sinai Hospital
🇺🇸Chicago, Illinois, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
The Cancer Institute At Alexian Brothers
🇺🇸Elk Grove Village, Illinois, United States
Cancer Center Of Kansas
🇺🇸Wichita, Kansas, United States
Hematology/Oncology Of The North Shore
🇺🇸Lake Forest, Illinois, United States
Healthcare Research Network III, LLC
🇺🇸Tinley Park, Illinois, United States
American Health Network
🇺🇸Avon, Indiana, United States
Hazard Arh Regional Medical Center
🇺🇸Hazard, Kentucky, United States
St Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Local Institution - 0009
🇺🇸Hackensack, New Jersey, United States
Weill Med Col Of Cornell
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Columbia University Medical Center (Cumc)
🇺🇸New York, New York, United States
Fred Hutchinson Can Res Ctr
🇺🇸Seattle, Washington, United States
Huntsman Cancer Hospital
🇺🇸Salt Lake City, Utah, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
St. Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Leo W.Jenkins Cancer Center
🇺🇸Greenville, North Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Northwest Oncology & Hematology, SC
🇺🇸Rolling Meadows, Illinois, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States