Chronic Phase Chronic Myeloid LeukemiaNCT03045120
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
An observational study of Chronic Phase Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 24 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Phase Chronic Myeloid Leukemia
- How many people
- 118 participants
- Where
- 24 sitesUnited States
- Study dates
- 19 Jul 2017to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
American Health Network
Avon, Indiana, 46123
St. Agnes Hospital
Baltimore, Maryland, 21229
St Vincent Frontier Cancer Center
Billings, Montana, 59102
Roswell Park Cancer Institute
Buffalo, New York, 14263
Mount Sinai Hospital
Chicago, Illinois, 60608
Oncology Hematology Care
Cincinnati, Ohio, 45202
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
The Cancer Institute At Alexian Brothers
Elk Grove Village, Illinois, 60007
Providence Regional Cancer Partnership
Everett, Washington, 98201
Leo W.Jenkins Cancer Center
Greenville, North Carolina, 27834
Local Institution - 0009
Hackensack, New Jersey, 07601
Hazard Arh Regional Medical Center
Hazard, Kentucky, 41701
Northwest Oncology & Hematology, SC
Hoffman Estates, Illinois, 60169
Hematology/Oncology Of The North Shore
Lake Forest, Illinois, 60045
Weill Med Col Of Cornell
New York, New York, 10021
Columbia University Medical Center (Cumc)
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Northwest Oncology & Hematology, SC
Rolling Meadows, Illinois, 60008
Huntsman Cancer Hospital
Salt Lake City, Utah, 84093
Fred Hutchinson Can Res Ctr
Seattle, Washington, 98109
Montefiore Medical Center
The Bronx, New York, 10467
Healthcare Research Network III, LLC
Tinley Park, Illinois, 60487
Cancer Center Of Kansas
Wichita, Kansas, 67214
About this study
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.
Read the 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.
- Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score
Measured: up to 24 months
changes in metabolic risk from baseline using metabolic lab values
Measured: up to 24 months
Secondary outcomes (12)
echocardiography to assess left ventricular function
Measured: up to 24 months
urinary protein excretion to assess early vascular endothelial changes
Measured: up to 24 months
coronary calcium scoring to assess coronary artery narrowing
Measured: up to 24 months
metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease
Measured: 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
Measured: up to 24 months
clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis
Measured: up to 24 months
clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis
Measured: up to 24 months
clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis
Measured: up to 24 months
time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments
Measured: 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
Measured: 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
Measured: up to 24 months
measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start19 Jul 2017
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Phase Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045120
- Sponsor's protocol ID
- CA180-653
- Status last verified
- Dec 2022
- First submitted
- 31 Jan 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03045120
- Acronym / sponsor ID
- CA180-653
- Conditions
- Chronic Phase Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Educational ResourceLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Phase Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.