Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

You may be eligible if

• DISEASE CHARACTERISTICS:
• Cytogenetically confirmed 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
• No leukemia beyond bone marrow, blood, liver, or spleen
• No chloroma
• Phase I (closed to accrual as of 7/9/03):
• * Philadelphia (Ph) chromosome-positive CML in chronic phase
• Phase II:
• * Newly diagnosed Ph chromosome-positive CML in chronic phase
• * Initial diagnosis within 6 months of study
• * No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride
• Phase I (closed to accrual as of 7/9/03) and II:
• * No identified sibling donors where allogeneic stem cell transplantation is elected as first-line therapy
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• 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 2 methods of effective barrier contraception during and for at least 3 months after study participation
• No other serious uncontrolled medical condition
• No autoimmune disease
• No prior noncompliance to medical regimens or potential unreliability
• No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I \[closed to accrual as of 7/9/03\])
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• See Disease Characteristics
• No prior bone marrow or peripheral blood stem cell transplantation
• At least 2 weeks since prior interferon alfa (phase I \[closed to accrual as of 7/9/03\])
• Chemotherapy:
• See Disease Characteristics
• At least 6 weeks since prior busulfan (phase I \[closed to accrual as of 7/9/03\] )
• At least 2 weeks since prior cytarabine (phase I \[closed to accrual as of 7/9/03\])
• No concurrent chemotherapy
• Concurrent hydroxyurea allowed during the first 3 months of study
• Endocrine therapy:
• Not specified
• Radiotherapy:
• Not specified
• Surgery:
• Not specified
• Other:
• At least 4 weeks since prior investigational agents other than imatinib mesylate (phase I \[closed to accrual as of 7/9/03\])
• No concurrent grapefruit juice
• Concurrent anagrelide hydrochloride allowed during the first 3 months of study