Spots Global Cancer Trial Database for 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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Trial Identification
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
Study ID: NCT03045120
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Northwest Oncology & Hematology, SC, Hoffman Estates, Illinois, United States
Hematology/Oncology Of The North Shore, Lake Forest, Illinois, United States
Northwest Oncology & Hematology, SC, Rolling Meadows, Illinois, United States
Healthcare Research Network III, LLC, Tinley Park, Illinois, United States
American Health Network, Avon, Indiana, United States
Cancer Center Of Kansas, Wichita, Kansas, United States
Hazard Arh Regional Medical Center, Hazard, Kentucky, United States
St. Agnes Hospital, Baltimore, Maryland, United States
St Vincent Frontier Cancer Center, Billings, Montana, United States
Local Institution - 0009, Hackensack, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Med Col Of Cornell, New York, New York, United States
Columbia University Medical Center (Cumc), New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Leo W.Jenkins Cancer Center, Greenville, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Fred Hutchinson Can Res Ctr, Seattle, Washington, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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