CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old

Inclusion Criteria:

• Newly diagnosed:

• Therapy-related acute myeloid leukemia (AML)

• AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocyticleukemia (CMML)

• AML with MDS-related changes (as per World Health Organization [WHO])

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

• Plasma creatinine =< 1.5 x upper limit of normal (ULN)

• Total bilirubin < 2.0 mg/dL

• Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN

• Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >= 50%

• Participants of child-bearing potential must agree to use adequate contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry. Should a woman become pregnant or suspect she is pregnant while she orher partner is participating in this study, she should inform her treating physicianimmediately

• Women of childbearing potential must have a negative serum or urine pregnancy testwithin 72 hours prior to enrollment and commit to two forms of birth control

• Men must use a latex condom during any sexual contact with women of childbearingpotential

• Willing to adhere to protocol specific requirements

• Participant or legal representative must understand the investigational nature ofthis study and sign an Independent Ethics Committee/Institutional Review Boardapproved written informed consent form prior to receiving any study relatedprocedure

Exclusion Criteria:

• Prior treatment of AML

• Known clinically active central nervous system (CNS) leukemia

• Core-binding factor leukemia

• Acute promyelocytic leukemia

• Uncontrolled other malignancy

• Prior anthracycline exposure > 368 mg/m^2 of daunorubicin or equivalent

• Cardiovascular disease resulting in heart failure (New York Heart Association classIII or IV), unstable angina (angina symptoms at rest), or new onset angina (beganwithin the last 3 months) or myocardial infarction within the past 6 months

• Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs

• Known active HIV infection

• Known history of active hepatitis B or C infection

• Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholicsteatohepatitis, sclerosing cholangitis)

• Evidence of ongoing, uncontrolled systemic infection

• Pregnant or breastfeeding women

• Subject with concurrent severe and/or uncontrolled medical or psychiatric conditionsthat in the opinion of the investigator may impair the participation in the study orthe evaluation of safety and/or efficacy

• History of Wilson disease or other copper-handling disorders

• Any condition which in the investigator's opinion deems the participant anunsuitable candidate to receive study drug