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
1 other identifier
observational
118
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2017
CompletedStudy Start
First participant enrolled
July 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedDecember 21, 2022
December 1, 2022
4.9 years
January 31, 2017
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score
up to 24 months
changes in metabolic risk from baseline using metabolic lab values
up to 24 months
Secondary Outcomes (12)
echocardiography to assess left ventricular function
up to 24 months
urinary protein excretion to assess early vascular endothelial changes
up to 24 months
coronary calcium scoring to assess coronary artery narrowing
up to 24 months
metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease
up to 24 months
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
- +7 more secondary outcomes
Study Arms (4)
dasatinib cohort
Intended to characterize the impact of dasatinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
imatinib cohort
Intended to characterize the impact of imatinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
nilotinib cohort
Intended to characterize the impact of nilotinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
bosutinib cohort
Intended to characterize the impact of bosutinib on cardiovascular and metabolic risk factors in CP-CML treated patients who are TKI naive and initiating first line TKIs in routine clinical practice in the US.
Eligibility Criteria
Newly-diagnosed, treatment-naïve CP-CML patients who are ≥ 18 years at the time of CP-CML diagnosis who are scheduled to initiate treatment with dasatinib, imatinib, nilotinib or Bosutinib are eligible for enrollment. Enrolled patients (n=200) will be distributed across the 3 patient treatment groups of newly diagnosed CP-CML patients who will initiate their first- line TKI treatment
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
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
Montefiore Medical Center
The Bronx, New York, 10467, 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
Related Links
Biospecimen
biomarker analyses will be collected for metabolic panels
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 7, 2017
Study Start
July 19, 2017
Primary Completion
June 20, 2022
Study Completion
June 20, 2022
Last Updated
December 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share