Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Phase Chronic Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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, 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

Primary outcomes:
measure: changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score
timeFrame: up to 24 months
measure: changes in metabolic risk from baseline using metabolic lab values
timeFrame: up to 24 months
Secondary outcomes:
measure: echocardiography to assess left ventricular function
timeFrame: up to 24 months
measure: urinary protein excretion to assess early vascular endothelial changes
timeFrame: up to 24 months
measure: coronary calcium scoring to assess coronary artery narrowing
timeFrame: up to 24 months
measure: metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease
timeFrame: up to 24 months
measure: 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
timeFrame: up to 24 months
measure: clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis
timeFrame: up to 24 months
measure: clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis
timeFrame: up to 24 months
measure: clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis
timeFrame: up to 24 months
measure: time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments
timeFrame: up to 24 months
measure: 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
timeFrame: up to 24 months
measure: description of the demographic and clinical patient characteristics associated with initial treatment choice and changes of treatment based on the medical records
timeFrame: up to 24 months
measure: measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mount Sinai Hospital
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: The Cancer Institute At Alexian Brothers
state: Illinois
city: Hoffman Estates
country: United States
facility: Northwest Oncology & Hematology, SC
state: Illinois
city: Lake Forest
country: United States
facility: Hematology/Oncology Of The North Shore
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Oncology & Hematology, SC
state: Illinois
city: Tinley Park
country: United States
facility: Healthcare Research Network III, LLC
state: Illinois
city: Avon
country: United States
facility: American Health Network
state: Indiana
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Hazard
country: United States
facility: Hazard Arh Regional Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Billings
country: United States
facility: St Vincent Frontier Cancer Center
state: Montana
city: Hackensack
country: United States
facility: Local Institution - 0009
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Med Col Of Cornell
state: New York
city: New York
country: United States
facility: Columbia University Medical Center (Cumc)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Greenville
country: United States
facility: Leo W.Jenkins Cancer Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Salt Lake City
country: United States
facility: Huntsman Cancer Hospital
state: Utah
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Can Res Ctr
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: