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
Conditions studied: Chronic Phase Chronic Myeloid Leukemia
In brief
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.
Key facts
- Study ID
- NCT03045120
- Run by
- Bristol-Myers Squibb
- People needed
- 118
- Starts
- 2017-07-19
- Expected to finish
- 2022-06-20
- Last updated by the study team
- 2022-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Mount Sinai Hospital — Chicago, Illinois, United States
- Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
- The Cancer Institute At Alexian Brothers — Elk Grove Village, Illinois, United States
- Northwest Oncology & Hematology, SC — Hoffman Estates, Illinois, United States
- Hematology/Oncology Of The North Shore — Lake Forest, Illinois, United States
- Northwest Oncology & Hematology, SC — Rolling Meadows, Illinois, United States
- Healthcare Research Network III, LLC — Tinley Park, Illinois, United States
- American Health Network — Avon, Indiana, United States
- Cancer Center Of Kansas — Wichita, Kansas, United States
- Hazard Arh Regional Medical Center — Hazard, Kentucky, United States
- St. Agnes Hospital — Baltimore, Maryland, United States
- St Vincent Frontier Cancer Center — Billings, Montana, United States
- Local Institution - 0009 — Hackensack, New Jersey, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Weill Med Col Of Cornell — New York, New York, United States
- Columbia University Medical Center (Cumc) — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Leo W.Jenkins Cancer Center — Greenville, North Carolina, United States
- Oncology Hematology Care — Cincinnati, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Huntsman Cancer Hospital — Salt Lake City, Utah, United States
- Providence Regional Cancer Partnership — Everett, Washington, United States
- Fred Hutchinson Can Res Ctr — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.