Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.

Exclusion Criteria

• •1. Current or anticipated use of additional investigational agents.
• •2. Any prior treatment for AML with the exception of corticosteroids, hydroxyurea, and/or leukapheresis to prevent or treat early complications prior to starting study therapy. Permitted prior therapy must be stopped 24 hours prior to starting study therapy.
• •3. Prior use of hypomethylating agents is permitted for patients with history of antecedent MDS. Last dose of hypomethylating therapy must have been 15 or more days prior to starting study therapy. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment.
• •4. Favorable risk cytogenetics as defined by 2017 ELN risk stratification including acute promyelocytic leukemia
• •5. Chronic myeloid leukemia in myeloid blast crisis
• •7. Clinical evidence of active CNS leukemia
• •8. Active or metastatic second malignancy
• •9. Any major surgery or radiation therapy within four weeks.
• •10. Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
• •11. Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
• •12. Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging)
• •13. Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for greater than or equal to 72 hrs.
• •14. Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have subsequent negative culture(s) to be eligible
• •15. Known HIV infection
• •16. Active hepatitis B or hepatitis C infection
• •17. Hypersensitivity to cytarabine, daunorubicin or liposomal products
• •18. History of Wilson's disease or copper-metabolism disorder
• •19. Pregnant or breastfeeding
• •20. Any condition which in the opinion of the investigator will interfere with the ability of the subject to comply with the requirements of the study