Myeloproliferative Neoplasms Clinical Trial
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
Summary
The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion Criteria:
Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study.
Men and women, 18 years of age 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 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 subjects 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.
Prior therapy with dasatinib (BMS-354825).
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.
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There is 1 Location for this study
Birmingham Alabama, , United States
Anaheim California, , United States
Los Angeles California, , United States
Stanford California, , United States
Vallejo California, , United States
Jacksonville Florida, , United States
Tampa Florida, , United States
Atlanta Georgia, , United States
Chicago Illinois, , United States
Kansas City Kansas, , United States
Baltimore Maryland, , United States
Boston Massachusetts, , United States
Detroit Michigan, , United States
St. Louis Missouri, , United States
Hackensack New Jersey, , United States
New York New York, , United States
Portland Oregon, , United States
Pittsburgh Pennsylvania, , United States
Nashville Tennessee, , United States
Dallas Texas, , United States
Houston Texas, , United States
Buenos Aires , , Argentina
Cordoba , , Argentina
St. Leonards New South Wales, , Australia
South Brisbane Queensland, , Australia
East Melbourne Victoria, , Australia
Parkville Victoria, , Australia
Wien , , Australia
B-Leuven , , Belgium
Edegem , , Belgium
Campinas , , Brazil
Rio De Janeiro , , Brazil
Sao Paulo , , Brazil
Toronto Ontario, , Canada
Aarhus , , Denmark
Helsinki , , Finland
LIlle , , France
Lyon Cedex 03 , , France
Nantes , , France
Paris , , France
Pessac , , France
Poitiers Cedex , , France
Strasbourg Cedex , , France
Hamburg , , Germany
Mainz , , Germany
Mannheim , , Germany
Ramat-Gan , , Israel
Bologna , , Italy
Napoli , , Italy
Orbassano , , Italy
Roma , , Italy
Jeollanam-Do , , Korea, Republic of
Kyunggi-Do , , Korea, Republic of
Seoul , , Korea, Republic of
Nijmegen , , Netherlands
Rotterdam , , Netherlands
Trondheim , , Norway
Lima , , Peru
Quezon City , , Philippines
Singapore , , Singapore
Gothenburg , , Sweden
Lund , , Sweden
Umea , , Sweden
Uppsala , , Sweden
Basel , , Switzerland
Taipei , , Taiwan
Taoyuan , , Taiwan
Bangkok , , Thailand
Glasgow Central, , United Kingdom
London Greater London, , United Kingdom
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