Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed chronic myelogenous leukemia (CML) In chronic phase Philadelphia chromosome (Ph)-positive No accelerated or blastic phase Accelerated phase CML is defined as ≥ 15% but < 30% blasts in peripheral blood or bone marrow OR ≥ 30% blasts and promyelocytes in peripheral blood or bone marrow provided that < 30% blasts were present OR ≥ 20% peripheral basophils OR platelet count < 100,000/mm^3, unrelated to therapy No less than 20 metaphases in the bone marrow sample No evidence of complete cytogenetic response to imatinib mesylate (complete cytogenetic response defined as 0% Ph-positive cells in bone marrow) Receiving continuous imatinib mesylate therapy for ≥ the past 9 months Dosage ≥ 600 mg/day for ≥ the past 3 months Stable dose of 600 mg/day for ≥ the past 4 weeks Achieved and maintained hematological response to imatinib mesylate as defined by all of the following: WBC < 20,000/mm^3 Basophils < 20% Less than 5% myelocytes and metamyelocytes in peripheral blood No blasts or promyelocytes in peripheral blood No evidence of disease-related symptoms or extramedullary disease, including enlarged spleen or liver PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic AST and ALT < 1.5 times upper limit of normal (ULN) Bilirubin < 1.5 times ULN (except for patients with Gilbert's disease) PTT < 1.5 times ULN (except for patients on oral anticoagulation therapy) INR < 1.5 times ULN (except for patients on oral anticoagulation therapy) Renal Creatinine < 1.5 times ULN Cardiovascular No angina No New York Heart Association class III or IV cardiac disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation HIV negative No history of non-compliance with medical regimens No hypercholesterolemia or hypertriglyceridemia (fasting state) ≥ grade 2 (despite lipid-lowering therapy) No diabetes mellitus No thyroid dysfunction No neuropsychiatric disorders No infection No other severe and/or uncontrolled medical condition that would preclude study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior allogeneic, syngeneic, or autologous bone marrow transplantation or stem cell transplantation for CML No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) Chemotherapy No prior chemotherapy regimens used in transplantation Endocrine therapy Not specified Radiotherapy Not specified Surgery Recovered from prior major surgery Other No prior sirolimus in combination with imatinib mesylate At least 4 weeks since prior investigational agents used in combination with imatinib mesylate and recovered No other concurrent investigational therapies No other concurrent anticancer agents
Sites / Locations
- Roswell Park Cancer Institute