The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Local Institution
Los Angeles, California, United States
Local Institution
San Francisco, California, United States
Local Institution
New York, New York, United States
To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
identify dose limiting toxicities
characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
measure major molecular response rate
measure the major cytogenetic response rate
characterize mutations in the BCR-ABL gene
evaluate progressive free survival and overall survival
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