CPX-351+GO in Subjects 55 Years Old, or Older, With AML (CPX GO)

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, De novo AML, Secondary AML, Therapy-related AML Read More

Inclusion Criteria:

• Ability to understand and voluntarily give informed consent
• Age≥55 years at the time of study treatment

• Pathological diagnosis of AML according to WHO criteria (with >20% blasts in the peripheral blood or bone marrow) including:

  • De novo AML with intermediate or adverse-risk karyotypes (including subjects with karyotypic abnormalities characteristic of MDS), who may have received treatment with low-dose cytarabine, hypomethylating agents, and/or non-intensive chemotherapy-based clinical trial treatments
  • Secondary AML: transformed from prior MDS or MPN, confirmed by bone marrow documentation of prior antecedent hematologic disorder
  • Therapy-related AML: t-AML, requires documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease
  • Performance status >50% KPS, ECOG 0-2

• Laboratory values fulfilling the following:

  • Peripheral blast count is less than 30,000/μL prior to administration of drug
  • Serum creatinine < 2.5 mg/dL
  • Serum total bilirubin < 2.5 mg/dL
  • Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN
  • Subjects with elevated liver enzymes and serum creatinine values secondary to AML are eligible after discussion with PI
  • Cardiac ejection fraction ≥ 50% by echocardiography, MUGA, or Cardiac MRI
  • Negative pregnancy test for non-menopausal women ≥ 55 years old
• Subjects with history of second malignancies in remission may be eligible if there is clinical evidence of disease stability off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Subjects maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.

Exclusion Criteria:

• Acute promyelocytic leukemia [t(15;17)], AML with karyotype inversion 16 or t(8;21)
• Clinical or morphologic evidence of active CNS leukemia
• Prior intensive chemotherapy for AML with anthracycline/cytarabine-based regimens, GO or other antibody targeting CD33 as a single agent and/ or prior HSCT. Subjects may have been treated with commercially available or investigational hypomethylating agents (e.g. decitabine, azacitidine, SGI-110), lenalidomide, or low-dose cytarabine (not to exceed 20 mg/m2 daily for 14 days for ≤ 6 cycles) or on clinical trials with combinations of low-intensity chemotherapy agents. No more than one agent or combination of agents can be given for treatment of AML prior to enrollment onto this protocol.
• Prior treatment including HMA, systemic chemotherapy, surgery, or radiation therapy must have been completed at least 7 days before start of study treatment or after discussion with PI. Treatment with investigational agents must have been completed at least 14 days prior to study drug treatment. Hydroxyurea is permitted for control of blood counts before the start of study treatment. Toxicities associated with prior therapies must have recovered to grade 1 or less prior to start of study treatment.
• Subjects with prior cumulative 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
• Subjects with myocardial impairment of any cause (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 Criteria (Class III or IV staging)
• Active or uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs.
• Subjects with current or recent evidence of invasive fungal infection (blood or tissue culture); subjects with recent fungal infection must have a subsequent negative cultures to be eligible
• Known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)
• Hypersensitivity to cytarabine, daunorubicin or liposomal products
• History of Wilson's disease or other copper-metabolism disorder
• History of prior bone marrow or solid organ transplantation