Bortezomib 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, accelerated phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) in chronic or accelerated phase, defined as having any of the following: Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30% PB or BM blasts and promyelocytes at least 20% PB or BM basophils at least 20% Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart or 50% increase in splenomegaly over 4 weeks) Clonal evolution defined as the presence of additional cytogenetic abnormalities other than the Ph chromosome Thrombocytopenia (platelet count less than 100,000/mm^3) unrelated to therapy Hemoglobin less than 7 g/dL unrelated to therapy or bleeding Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to receive it Ineligible for higher-priority or higher-efficacy regimens or protocols No blastic phase CML PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: At least 18 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: No other concurrent illness that would preclude study entry Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or hydroxyurea At least 4 weeks since prior chemotherapy and recovered Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: See Disease Characteristics See Chemotherapy At least 24 hours since prior imatinib mesylate No other concurrent investigational agents
Sites / Locations
- MD Anderson Cancer Center at University of Texas