CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for theduration of the study

• Male or female, aged ≥18 and ≤70 years with newly diagnosed any risk AML as definedby ELN 2017 criteria

• For females of child-bearing potential: use of highly effective contraception uponenrollment and during study participation and for an additional 6 months after theend of CPX-351 and Gemtuzumab ozogamicin administration: A female of child-bearingpotential is considered when a sexually mature female: 1) has not undergone ahysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausalfor at least 12 consecutive months

• The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus areunknown. For this reason, women of child-bearing potential as defined above musthave a negative serum or urine pregnancy test within 24 hours prior to beginningstudy treatment.

• For males of reproductive potential: use of condoms or other methods to ensureeffective contraception with partner

• Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry

• ECOG ≤ 2 and eligible to receive intensive chemotherapy as determined by thetreating 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 whenused for non-AML diagnoses is allowed. Most recent dose must have been ≥14 daysprior to day 1 of study treatment.

• Participants must have acceptable organ function

• Adequate cardiac function defined as ejection fraction of ≥50% as determined bymultigated 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, sclerosingcholangitis) 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-studyanthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent).For participants who have received radiation therapy to the mediastinum, the totalcumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(orequivalent).

• Hemodynamically unstable (subjects requiring vasopressor support will not beeligible).

• Treatment with another investigational drug within 14 days.

• Uncontrolled cardiac disease including congestive heart failure class III or IV bythe NYHA, unstable angina (angina symptoms at rest), new onset angina (began withinthe last 3 months) or myocardial infarction within the past 6 months.

• Any disorder that compromises the subject's ability to give written informed consentand/or to comply with study procedures.

• Any substance abuse, severe and/or uncontrolled medical, social or psychiatricconditions that may prevent the subject from completing the study, interfere withthe evaluation of safety and/or efficacy, or interfere with the interpretation ofthe study results.

• Female subject who is pregnant or breastfeeding.

• Any patient with a known FLT3 ITD or FLT3 TKD mutation