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

Chronic Phase Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045120
• Other study ID #: CA180-653
• Status: Completed
• Start date: July 19, 2017
• Est. completion date: June 20, 2022

Study information

• Verified date: December 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years at the time of Ph+ CP-CML diagnosis

2. Newly diagnosed chronic phase of Ph+ CP-CML, confirmed with cytogenetic and/or molecular testing at baseline

3. Treatment-naïve and initiating treatment with dasatinib, imatinib, nilotinib or bosutinib

4. Willingness and ability to comply with routine office visits

Exclusion Criteria:

1. Any other prior or active non-CML active malignancy for which the patient is receiving treatment

2. Participation in a therapeutic clinical trial for CML disease

Related Conditions & MeSH terms

• Chronic Phase Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score		up to 24 months
Primary	changes in metabolic risk from baseline using metabolic lab values		up to 24 months
Secondary	echocardiography to assess left ventricular function		up to 24 months
Secondary	urinary protein excretion to assess early vascular endothelial changes		up to 24 months
Secondary	coronary calcium scoring to assess coronary artery narrowing		up to 24 months
Secondary	metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease		up to 24 months
Secondary	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
Secondary	clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis		up to 24 months
Secondary	clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis		up to 24 months
Secondary	clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis		up to 24 months
Secondary	time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments		up to 24 months
Secondary	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
Secondary	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
Secondary	measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease		up to 24 months

External Links

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