SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Trial Parameters
Brief Summary
The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .
Eligibility Criteria
Inclusion Criteria: 1. Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \> 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.; 2. Age ≥ 18 and \< 60 years; 3. Subjects who are positive for FLT3 mutations by central laboratory; 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 5. Subject must meet the following criteria as indicated on the clinical laboratory tests; 1. Serum aspartate aminotransf 2. Total serum bilirubin ≤ 2.5 x institutional ULN 3. Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \> 30 ml/min 6. Subject is suitable for oral administration of study drug. Exclusion Criteria: 1. Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia); 2. Diagnosis of active malignancy other than AML; 3. AML secondary to radiotherapy or chemo