CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia

This is an interventional treatment trial for Acute Myeloid Leukemia Read More

Inclusion Criteria:

• Ability to understand and voluntarily sign an informed consent form
• Pathological diagnosis of AML according to World Health Organization (WHO) criteria (with at least 20% blasts in the peripheral blood or bone marrow): newly diagnosed de novo AML; except for acute promyelocytic leukemia (APL); newly diagnosed secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS], myeloproliferative disease [MPD] or history of cytotoxic treatment for non-hematologic malignancy) or apparent de novo AML with MDS-associated karyotype
• Eastern Cooperative Oncology Group (ECOG) performance status 0-3
• Serum creatinine =< 2.0 mg/dL
• Serum total bilirubin =< 2.0 mg/dL
• Serum alanine aminotransferase < 3 times the upper limit of normal (ULN); Note: If elevated liver enzymes are related to disease alanine aminotransferase (ALT) should be < 5 times ULN

• To be considered at high risk for induction mortality patients must have 1 or 2 of the following risk factors (patients >= 60 must have at least 1 risk factor, patients < 60 must have at least 2 risk factors) present; at least one risk factor in every patient must be an AML-related factor:

  • AML-related factors include:

    • Antecedent hematologic disorder (AHD) (MDS, chronic myelomonocytic leukemia [CMML], or MPD) or history of exposure to cytotoxic chemotherapy [therapy-related (t)-AML]), or WHO-defined AML with MDS-related changes or apparent de novo AML with MDS-associated karyotype
    • Unfavorable cytogenetics as defined by the European Leukemia Net

  • Patient-related factors:

    • Age >= 70
    • ECOG performance status (PS) >= 2

  • Co-morbidities:

    • Serum creatinine > 1.3 g/dL
• Cardiac ejection fraction >= 50% by echocardiography or multi gated acquisition (MUGA) (when left ventricular ejection fraction [LVEF] expressed as a range, at least the upper limit should include 50%)
• Able to adhere to the study visit schedule and other protocol requirements
• All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile

Exclusion Criteria:

• Patients with history of second malignancy are eligible if they have documentation of disease stability, off therapy, based on computed tomography (CT) scan or other measures for the 6 months prior to entry in core
• Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent
• Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry in core
• Evidence of active central nervous system (CNS) leukemia
• Pregnant or lactating women
• Uncontrolled infection; to be eligible, patients receiving treatment for an infection (antibiotic, antifungal or antiviral treatment) must be afebrile (< 38.3 degrees Celsius [C]) and without hemodynamic instability or dyspnea from pneumonia for > 48 hours (hrs) prior to the start of induction therapy
• Hypersensitivity to cytarabine, daunorubicin or liposomal products
• History of Wilson's disease or other copper-metabolism disorder