Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Eligibility Criteria
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
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- OHSU Knight Cancer Institute