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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib in combination with imatinib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Los Angeles | California | United States | |||
| Local Institution |
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| 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 |
| San Francisco |
| California |
| United States |
| Local Institution | New York | New York | United States |
| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
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