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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

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ClinicalTrials.gov Identifier: NCT03045120
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 200 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 : March 29, 2017
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : July 31, 2021


Group/Cohort
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.



Primary Outcome Measures :
  1. changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score [ Time Frame: up to 24 months ]
  2. changes in metabolic risk from baseline using metabolic lab values [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. echocardiography to assess left ventricular function [ Time Frame: up to 24 months ]
  2. urinary protein excretion to assess early vascular endothelial changes [ Time Frame: up to 24 months ]
  3. coronary calcium scoring to assess coronary artery narrowing [ Time Frame: up to 24 months ]
  4. metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease [ Time Frame: up to 24 months ]
  5. 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 ]
  6. clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
  7. clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
  8. clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis [ Time Frame: up to 24 months ]
  9. time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments [ Time Frame: up to 24 months ]
  10. 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 ]
  11. 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 ]
  12. 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

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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, or nilotinib 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:

  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, or nilotinib
  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

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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Show Show 26 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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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: August 2, 2018
Last Verified: August 2018
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