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 |
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).
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
University of Miami A private research university with more than 15,000 students from around the...
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Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1400 South Orange Avenue
Orlando, Florida 32806
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
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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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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303 E Chicago Ave
Chicago, Illinois 60611
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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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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1515 Holcombe Blvd
Houston, Texas 77030
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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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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3322 West End Avenue
Nashville, Tennessee 37203
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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Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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660 S Euclid Ave
Saint Louis, Missouri 63110
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
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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