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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

NCT ID: NCT03045120

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-19

Study Completion Date

2022-06-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Phase Chronic Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Mount Sinai Hospital

Chicago, Illinois, United States

Site Status

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Site Status

The Cancer Institute At Alexian Brothers

Elk Grove Village, Illinois, United States

Site Status

Northwest Oncology & Hematology, SC

Hoffman Estates, Illinois, United States

Site Status

Hematology/Oncology Of The North Shore

Lake Forest, Illinois, United States

Site Status

Northwest Oncology & Hematology, SC

Rolling Meadows, Illinois, United States

Site Status

Healthcare Research Network III, LLC

Tinley Park, Illinois, United States

Site Status

American Health Network

Avon, Indiana, United States

Site Status

Cancer Center Of Kansas

Wichita, Kansas, United States

Site Status

Hazard Arh Regional Medical Center

Hazard, Kentucky, United States

Site Status

St. Agnes Hospital

Baltimore, Maryland, United States

Site Status

St Vincent Frontier Cancer Center

Billings, Montana, United States

Site Status

Local Institution - 0009

Hackensack, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Weill Med Col Of Cornell

New York, New York, United States

Site Status

Columbia University Medical Center (Cumc)

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Leo W.Jenkins Cancer Center

Greenville, North Carolina, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Huntsman Cancer Hospital

Salt Lake City, Utah, United States

Site Status

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status

Fred Hutchinson Can Res Ctr

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Educational Resource

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

http://www.bms.com/clinical_trials/investigator_sponsored_research/Pages/expanded-access-program.aspx

EAP Investigator Requests

Other Identifiers

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CA180-653

Identifier Type: -

Identifier Source: org_study_id