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:

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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.

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.

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
Baltimore, Maryland 21229
Phone: 667-234-2966
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3550 Jerome Avenue
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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Bronx, NY
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666 Elm Street
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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Buffalo, NY
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3181 Southwest Sam Jackson Park Road
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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Portland, OR
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1100 Fairview Avenue North
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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Avon, Indiana
Phone: 317-745-8000
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Billings, Montana 59101
Phone: 406-238-6288
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Chicago, Illinois 60608
Phone: 872-222-7830
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Chicago, IL
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cincinnati, OH
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800 Biesterfield Road
Elk Grove Village, Illinois 60007
Phone: 630-269-2788
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Elk Grove Village, IL
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1717 13th St
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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Everett, WA
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Greenville, North Carolina 27834
Phone: 252-744-1015
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Hackensack, New Jersey 07601
Phone: 551-996-3416
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200 Medical Center Drive
Hazard, Kentucky 41701
Phone: 606-487-7902
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New York, New York 10065
Phone: 646-962-9359
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1275 York Ave
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
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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Normal, Illinois 61761
Phone: 309-451-2207
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-4828
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Rolling Meadows, Illinois 60008
Phone: 872-222-7830
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Salt Lake City, Utah 84112
Phone: 801-213-4327
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Shreveport, Louisiana 71103
Phone: 318-212-8671
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Phone: 631-638-2148
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Tinley Park, Illinois 60487
Phone: 314-972-9600
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Tucson, Arizona 85724
Phone: 520-626-6931
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818 N. Emporia, #403
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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