CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

Inclusion Criteria:

1. De novo AML
2. No MRC-defining cytogenetic lesion
3. No t(15;17), t(8;21), inv(16) or t(16;16)
4. No NPM1 gene mutation
5. No FLT3 mutated AML (FLT3 ITD or TKD)
6. Not previously treated except for short course hydroxyurea in patients presenting withhigh WBC count and/or tumor symptoms,
7. Age ≥ 50 years,
8. Performance status ≤ 2 (ECOG grading),
9. Patient must have adequate organ function as indicated detailed with laboratory valuesin the section IV of the protocol
10. Female patient of childbearing potential with a negative serum pregnancy test (β-hCG)within 72 hours prior to receiving the first dose of CPX-351 or 7+3. Female patientwho is not actively breastfeeding at the time of study entry.
11. Female patient is either post-menopausal, free from menses for > 2 years, surgicallysterilized or willing to use 2 adequate barrier methods of contraception to preventpregnancy, or agrees to not become pregnant throughout the study, starting with studyscreening
12. Male patient agrees to use an adequate method of contraception for the duration of thestudy. Men should be advised not to father a child while receiving CPX-351 or 7+3 andfor 3 months after the last dose of study treatment .
13. Patient is available for periodic blood sampling, study related assessments, andappropriate clinical management at the treating institution for the duration of thestudy.
14. Patient has the ability to understand and willingness to sign an informed consent formindicating the investigational nature of the study.
15. Patient registered to the French Social Security.

Exclusion Criteria:

1. Prior history of documented MDS, MPN or MDS/MPN, tAML
2. Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer)
3. Patient has active and uncontrolled infection.
4. Patient has uncontrolled intercurrent illness or circumstances that could limitcompliance with the study, including but not limited to the following: symptomaticcongestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia,pancreatitis, or psychiatric or social conditions that may interfere with patientcompliance.
5. Patient is currently participating or has participated in a study with aninvestigational compound or device within 30 days of initial dosing with study drug.
6. Patient has known human immunodeficiency virus (HIV) infection or HIV-relatedmalignancy.
7. Patient has clinically active hepatitis B or hepatitis C infection.
8. Patient has a known allergy or hypersensitivity to any component of CPX-351,idarubicin or cytarabine.
9. Patient with a "currently active" second malignancy, other than nonmelanoma skincancer and carcinoma in situ of the cervix, should not be enrolled. Patients are notconsidered to have a "currently active" malignancy if they have completed therapy fora prior malignancy, are disease free from prior malignancies for >1 year or areconsidered by their physician to be at less than 30% risk of relapse.
10. Patients with clinical evidence of CNS leukemia.
11. Cardiac ejection fraction <50% or considered as abnormal by echocardiography ormulti-gated acquisition (MUGA) scan.
12. Patient is pregnant or breastfeeding within the projected duration of the study.