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.

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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.

View Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

118

Study ID:

NCT03045120

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 23 Locations for this study

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Mount Sinai Hospital
Chicago Illinois, 60608, United States
Alexian Brothers Medical Center
Elk Grove Village Illinois, 60007, United States
The Cancer Institute At Alexian Brothers
Elk Grove Village Illinois, 60007, United States
Northwest Oncology & Hematology, SC
Hoffman Estates Illinois, 60169, United States
Hematology/Oncology Of The North Shore
Lake Forest Illinois, 60045, United States
Northwest Oncology & Hematology, SC
Rolling Meadows Illinois, 60008, United States
Healthcare Research Network III, LLC
Tinley Park Illinois, 60487, United States
American Health Network
Avon Indiana, 46123, United States
Cancer Center Of Kansas
Wichita Kansas, 67214, United States
Hazard Arh Regional Medical Center
Hazard Kentucky, 41701, United States
St. Agnes Hospital
Baltimore Maryland, 21229, United States
St Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Local Institution - 0009
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Weill Med Col Of Cornell
New York New York, 10021, United States
Columbia University Medical Center (Cumc)
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Leo W.Jenkins Cancer Center
Greenville North Carolina, 27834, United States
Oncology Hematology Care
Cincinnati Ohio, 45202, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Huntsman Cancer Hospital
Salt Lake City Utah, 84093, United States
Providence Regional Cancer Partnership
Everett Washington, 98201, United States
Fred Hutchinson Can Res Ctr
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

118

Study ID:

NCT03045120

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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