Myeloproliferative Neoplasms 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
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 leukemia-cml/" >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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
≥ 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
Exclusion Criteria:
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
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There are 23 Locations for this study
Chicago Illinois, 60608, United States
Elk Grove Village Illinois, 60007, United States
Elk Grove Village Illinois, 60007, United States
Hoffman Estates Illinois, 60169, United States
Lake Forest Illinois, 60045, United States
Rolling Meadows Illinois, 60008, United States
Tinley Park Illinois, 60487, United States
Avon Indiana, 46123, United States
Wichita Kansas, 67214, United States
Hazard Kentucky, 41701, United States
Baltimore Maryland, 21229, United States
Billings Montana, 59102, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
New York New York, 10032, United States
New York New York, 10065, United States
Greenville North Carolina, 27834, United States
Cincinnati Ohio, 45202, United States
Portland Oregon, 97239, United States
Salt Lake City Utah, 84093, United States
Everett Washington, 98201, United States
Seattle Washington, 98109, United States
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