Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML



Status:Completed
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:July 2005
End Date:July 2014

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A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia
chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant
to imatinib mesylate (Gleevec).


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase
chronic myeloid leukemia whose disease has primary or acquired hematologic resistance
to imatinib mesylate or who are intolerant of imatinib mesylate.

- Men and women, 18 years or older

- Adequate hepatic function

- Adequate renal function

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least 1
month before and at least 3 months after the study in such a manner that the risk of
pregnancy is minimized.

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Subjects who are eligible and willing to undergo transplantation during the screening
period

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy

- Uncontrolled or significant cardiovascular disease

- Medications that increase bleeding risk

- Medications that change heart rhythms

- Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent

- History of significant bleeding disorder unrelated to CML

- Concurrent incurable malignancy other than CML

- Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study
We found this trial at
41
sites
Anaheim, California 92801
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Vallejo, California 94589
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Atlanta, Georgia 30341
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Baltimore, Maryland 20742
(301) 405-1000
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Boston, Massachusetts 02115
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Detroit, Michigan 48201
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
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La Plata, Buenos Aires
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Las Vegas, Nevada 89135
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Lawrenceville, Georgia 30046
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Lexington, Kentucky
859) 257-9000
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Loma Linda, California 92354
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Long Beach, California 90813
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Los Angeles, California 90095
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New Brunswick, New Jersey 08901
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New York, New York 10032
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Omaha, Nebraska 68198
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Peoria, IL
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Pittsburgh, Pennsylvania 15224
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington, District of Columbia 20010
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Westwood, Kansas 66205
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