A Phase 1/1b Dose Escalation and Expansion of CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed Acute Myeloid Leukemia

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 and ≤70 years with newly diagnosed any risk AML as defined by ELN 2017 criteria * For females of child-bearing potential: use of highly effective contraception upon enrollment and during study participation and for an additional 6 months after the end of CPX-351 and Gemtuzumab ozogamicin administration: A female of child-bearing potential is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months * The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus are unknown. For this reason, women of child-bearing potential as defined above must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner * Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry * ECOG ≤ 2 and eligible to receive intensive chemotherapy as determined by the treating physician * Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed. * Prior hypomethylating agents (HMA) therapy including azacitidine or decitabine when used for non-AML diagnoses is allowed. Most recent dose must have been ≥14 days prior to day 1 of study treatment. * Participants must have acceptable organ function * Adequate cardiac function defined as ejection fraction of ≥50% as determined by multigated acquisition scan (MUGA) or 2D echocardiogram. * Hydroxyurea is allowed for cytoreduction until day 1 of study treatment Exclusion Criteria: * Prior treatment of AML except hydroxyurea and/or leukapheresis * Participants with acute promyelocytic leukemia (APL). * Known current and clinically active central nervous system (CNS) leukemia. * Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease. * Participants with known active infection with hepatitis B or hepatitis C virus * Known allergic reactions to components of the CPX-351 (cytarabine or daunorubicin) or Gemtuzumab ozogamicin. * Patients with any prior anthracycline exposure plus any planned on-study anthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent). For participants who have received radiation therapy to the mediastinum, the total cumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(or equivalent). * Hemodynamically unstable (subjects requiring vasopressor support will not be eligible). * Treatment with another investigational drug within 14 days. * Uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months. * Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures. * Any substance abuse, severe and/or uncontrolled medical, social or psychiatric conditions that may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results. * Female subject who is pregnant or breastfeeding. * Any patient with a known FLT3 ITD or FLT3 TKD mutation