Trial record 1 of 1 for:
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
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| ClinicalTrials.gov Identifier: NCT03045120 |
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Recruitment Status :
Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : May 25, 2021
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease |
|---|
| Chronic Phase Chronic Myeloid Leukemia |
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.
| Study Type : | Observational |
| Actual Enrollment : | 118 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | July 19, 2017 |
| Estimated Primary Completion Date : | June 22, 2022 |
| Estimated Study Completion Date : | June 22, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Chronic myeloid leukemia
| Group/Cohort |
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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.
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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.
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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.
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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.
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Primary Outcome Measures :
- changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score [ Time Frame: up to 24 months ]
- changes in metabolic risk from baseline using metabolic lab values [ Time Frame: up to 24 months ]
Secondary Outcome Measures :
- echocardiography to assess left ventricular function [ Time Frame: up to 24 months ]
- urinary protein excretion to assess early vascular endothelial changes [ Time Frame: up to 24 months ]
- coronary calcium scoring to assess coronary artery narrowing [ Time Frame: up to 24 months ]
- metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease [ Time Frame: 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 [ Time Frame: up to 24 months ]
- clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
- clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
- clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
- time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments [ Time Frame: up to 24 months ]
- 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 [ Time Frame: up to 24 months ]
- description of the demographic and clinical patient characteristics associated with initial treatment choice and changes of treatment based on the medical records [ Time Frame: up to 24 months ]
- measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease [ Time Frame: up to 24 months ]
Biospecimen Retention: Samples With DNA
biomarker analyses will be collected for metabolic panels
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045120
Locations
Show 25 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03045120 |
| Other Study ID Numbers: |
CA180-653 |
| First Posted: | February 7, 2017 Key Record Dates |
| Last Update Posted: | May 25, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |