Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult acute megakaryoblastic leukemia (M7), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia without maturation (M1), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), blastic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) or blastic phase chronic myelogenous leukemia (CML) Refractory AML defined as any of the following: Failure to achieve complete response (CR) after 2 courses of induction chemotherapy Persistent bone marrow blasts > 40% after 1 course of induction chemotherapy Relapse of disease within 3 months since CR Relapsed AML defined as the following: Any evidence of disease recurrence after CR (early relapse occurs within 3-12 months and late relapse occurs > 12 months later) No acute promyelocytic leukemia (AML-M3 FAB subgroup) PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin ≤ 2.0 mg/dL AST ≤ 2.5 times upper limit of normal No known chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal Creatinine < 2.5 mg/dL (if 2.0-2.5 mg/dL, glomerular filtration rate must be measured and dose of cytarabine adjusted if necessary) Cardiovascular No New York Heart Association grade III-IV heart disease No congestive heart failure No myocardial infarction within the past 6 months Ejection fraction ≥ 30% Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment No uncontrolled systemic active infection No known HIV infection No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No history of other curatively treated malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent biologic agents Chemotherapy See Disease Characteristics No other concurrent chemotherapy Endocrine therapy No concurrent birth control pills Other More than 1 week since any prior investigational agent No other concurrent investigational agents or therapies No other concurrent anticancer agents No concurrent therapeutic anticoagulation with warfarin Low molecular weight heparin or heparin allowed for therapeutic anticoagulation Mini-dose warfarin (e.g., 1 mg per day) allowed for prophylaxis of central venous catheter thrombosis
Sites / Locations
- James P. Wilmot Cancer Center at University of Rochester Medical Center