Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
Condition: Acute Myeloid Leukemia
Intervention: CPX-351; Cytarabine; Daunorubicin
Intervention MeSH terms: Cytarabine; Daunorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acute; Myeloid; Leukemia; elderly; Newly; Diagnosed

Summary:

      The study investigates if CPX-351 will be a) more effective than the standard AML treatment
      and b) more tolerable than the standard AML treatment regimens.

      The study compares the investigational product CPX-351 vs the standard treatment for AML in
      this patients age group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥60 and <76 years at the time of diagnosis of AML

          -  Pathological confirmation of AML

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Laboratory values fulfilling the following:

        Serum creatinine < 2.0 mg/dL Serum total bilirubin < 2.0 mg/dL Serum alanine
        aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver
        enzymes are related to disease; contact medical monitor to discuss.

          -  Cardiac ejection fraction > 50% by echocardiography or MUGA scan

        Exclusion Criteria:

          -  Patients with locally advanced or metastatic solid tumors ≤5 years from initial
             diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5
             years from initial diagnosis, for whom the investigator has no clinical suspicion of
             active disease for >2 years before randomization are eligible)

          -  Prior treatment for AML; only hydroxyurea is permitted (see below)

          -  Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21)
             or inv16 if known at the time of randomization

          -  Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin
             (or equivalent)

          -  Any serious medical condition, laboratory abnormality or psychiatric illness that
             would prevent obtaining informed consent

          -  Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose;
             in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24
             hours before the start of study treatment

          -  Clinical evidence of active CNS leukemia

          -  Patients with history of and/or current evidence of myocardial impairment (e.g.
             cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive
             heart disease, and congestive heart failure) resulting in heart failure by New York
             Heart Association Class III or IV staging

          -  Active and uncontrolled infection. Patients with an infection receiving treatment with
             antibiotics may be entered into the study if they are afebrile and hemodynamically
             stable for 72 hrs.

          -  Current evidence of invasive fungal infection (blood or tissue culture); HIV or active
             hepatitis C infection

          -  Hypersensitivity to cytarabine, daunorubicin or liposomal products

          -  History of Wilson's disease or other copper-related disorder