The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
Major and overall hematologic response rates
Time frame: throughout the study
Durability of hematologic response and time to hematologic response (major and overall)
Time frame: throughout the study
Assess cytogenetic and molecular responses
Time frame: throughout the study
Measure minor hematologic response rate in the imatinib resistant group
Time frame: throughout the study
Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene
Time frame: throughout the study
Measure the heath-related QOL using FACT-G
Time frame: throughout the study
To assess safety and tolerability of dasatinib
Time frame: throughout the study
Population PK
Time frame: first month
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Birmingham, Alabama, United States
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Jacksonville, Florida, United States
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Kansas City, Kansas, United States
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