Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML) Less than 15% blasts in peripheral blood or bone marrow Less than 30% blasts and promyelocytes in peripheral blood or bone marrow Less than 20% basophils in blood or bone marrow Platelet count at least 100,000/mm^3 Philadelphia chromosome positive No more than 6 months since initial diagnosis No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma) Refused allogeneic stem cell transplantation as first-line therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No other serious uncontrolled medical condition No history of noncompliance to medical regimens or potential unreliability PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic therapy for CML Chemotherapy: No prior chemotherapy for CML except hydroxyurea Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for CML Radiotherapy: No prior radiotherapy for CML Surgery: Not specified Other: More than 28 days since prior investigational anticancer agents Prior anagrelide hydrochloride for CML allowed Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed No concurrent grapefruit juice or grapefruit
Sites / Locations
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Experimental
Cytarabine/ Imatinib Mesylate