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NCT03045120

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

Completed Last updated 21 December 2022
What this trial tests

trial in Chronic Phase Chronic Myeloid Leukemia in 118 participants. Completed in 20 June 2022.

Timeline
19 July 2017
Primary endpoint
20 June 2022
20 June 2022

Quick facts

Lead sponsorBristol-Myers Squibb
StatusCompleted
Study typeOBSERVATIONAL
Enrollment118
Start date19 July 2017
Primary completion20 June 2022
Estimated completion20 June 2022
Sites24 locations across United States

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Chronic Phase Chronic Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cardiometabolic Consequences of Targeted Anticancer Therapies.
    Guha A, Gong Y, DeRemer D, Owusu-Guha J, et al · · 2022 · cited 5× · PMID 34654781 · DOI 10.1097/fjc.0000000000001149

Verify or expand the search:

Other recruiting trials for Chronic Phase Chronic Myeloid Leukemia

Currently open trials in the same condition.

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing