cpx-351 for the treatment of secondary acute myeloid leukemia in patients younger than 60 years old

Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Acute Myeloid Leukemia With Myelodysplasia-Related Changes; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia

Summary: this phase ii trial studies how well liposome-encapsulated daunorubicin-cytarabine (cpx-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. drugs used in chemotherapy, such as cpx-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

primary objective: i. to determine the complete response rate including morphologic complete remission (cr) and morphologic complete remission with incomplete blood count recovery (cri) as defined by the international working group criteria. secondary objective: i. to determine cr + cri duration, event free survival (efs), overall survival (os), patients successfully proceeding to allogenic hematopoietic cell transplant, and adverse events (ae). outline: induction: patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (iv) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. re-induction: patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine iv over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. consolidation: beginning 5-8 weeks after the start of the last induction, patients who achieve cr receive liposome-encapsulated daunorubicin-cytarabine iv over 90 minutes on days 1 and 3. treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up at 30 days, and then every 3 months for up to 5 years.

Eligibility criteria:
inclusion criteria: * newly diagnosed: * therapy-related acute myeloid leukemia (aml) * aml with antecedent myelodysplastic syndrome (mds) or chronic myelomonocytic leukemia (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 contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * women of childbearing potential must have a negative serum or urine pregnancy test within 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 childbearing potential * willing to adhere to protocol specific requirements * participant or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure 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 class iii or iv), unstable angina (angina symptoms at rest), or new onset angina (began within 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, nonalcoholic steatohepatitis, sclerosing cholangitis) * evidence of ongoing, uncontrolled systemic infection * pregnant or breastfeeding women * subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the 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 an unsuitable candidate to receive study drug