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
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/4/2018 |
Start Date: | March 29, 2017 |
End Date: | July 31, 2021 |
Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
Email: | Clinical.Trials@bms.com |
Phone: | please email: |
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.
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.
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.
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.
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
We found this trial at
26
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Phone: 503-418-9117
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Phone: 718-920-2006
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-1516
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Phone: 206-667-1997
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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800 Biesterfield Road
Elk Grove Village, Illinois 60007
Elk Grove Village, Illinois 60007
Phone: 630-269-2788
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1717 13th St
Everett, Washington 98201
Everett, Washington 98201
(425) 297-5500
Phone: 425-297-5531
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-1001
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-304-5485
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Rolling Meadows, Illinois 60008
Phone: 872-222-7830
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Stony Brook, New York 11794
Phone: 631-638-2148
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818 N. Emporia, #403
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 262-4467
Phone: 316-613-4318
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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