Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm

Inclusion Criteria

• •Diagnosis of newly secondary AML according to WHO 2016 classification following an antecedent of Myeloproliferative Neoplasm including Essential Thrombocythemia (ET), Polycythemia Vera (PV), primary or secondary Myelofibrosis
• •Performance status 2 Eastern Cooperative Oncology Group (ECOG) grading.
• •Eligible for standard intensive chemotherapy
• •Absence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by multigated acquisition (MUGA) scan or echocardiogram. Cardiac ejection fraction ≥ 50% by echocardiography ou MUGA
• •Patient must have adequate organ function as indicated by the following laboratory values:
• •* Renal
• •* Serum creatinine: \< 2 mg/dl OR calculated creatinine clearance\*: ≥ 30 mL/min by MDRD formula for patients with creatinine levels \> 1.5 X institutional Upper Limit Normal (ULN)
• •* Hepatic
• •* Serum total bilirubin: ≤ 2.5 X ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels ≥ 2 mg/dL unless Gilbert's Syndrome
• •* Aspartate-Amino-Transferase (ASAT) and Alanine-Transaminase (ALAT): ≤ 2.5 times ULN
• •* Alkaline Phosphatase: ≤ 5 X ULN, if \> 2.5 X ULN, then liver fraction should be ≤ 2.5 X ULN \*Creatinine clearance should be calculated per institutional standard
• •Life expectancy should be of 12 weeks at least according to investigator evaluation
• •Female patients of childbearing potential must have a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351. Female patients who are not post-menopausal, free from menses for \> 2 years or surgically sterilized, will have to use adequate barrier methods of contraception to prevent pregnancy or agree to abstain from becoming pregnant throughout the study, starting with Visit 1.
• •Male patients agree to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 and for 3 months post study.
• •Patients have the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.