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

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 Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • The Cancer Institute at Alexian Brothers
    • Hoffman Estates, Illinois, United States, 60169
      • Northwest Oncology & Hematology, SC
    • Lake Forest, Illinois, United States, 60045
      • Hematology/Oncology of the North Shore
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Oncology & Hematology, SC
    • Tinley Park, Illinois, United States, 60487
      • Healthcare Research Network III, LLC
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Hazard ARH Regional Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • St. Agnes Hospital
  • Montana
    • Billings, Montana, United States, 59102
      • St Vincent Frontier Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0009
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center (CUMC)
    • New York, New York, United States, 10021
      • Weill Med Col Of Cornell
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Leo W.Jenkins Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45202
      • Oncology Hematology Care
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Utah
    • Salt Lake City, Utah, United States, 84093
      • Huntsman Cancer Hospital
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Can Res Ctr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis	up to 24 months
clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis	up to 24 months
clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis	up to 24 months
time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments	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	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	up to 24 months
measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease	up to 24 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls
• EAP Investigator Requests
• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: CA180-653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No