Omacetaxine Mepesuccinate after Cytarabine and Daunorubicin Hydrochloride, Idarubicin, or Mitoxantrone Hydrochloride in Treating Older Patients with Acute Myeloid Leukemia in First Remission

Inclusion Criteria

• Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria
• Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status (PS) and vital organ function at the discretion of the treating physician
• Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible
• Provide signed written informed consent
• Be able to comply with study procedures and follow-up examinations
• Be non-fertile or not pregnant or lactating & agree to use birth control during the study through the end of last treatment visit
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); and
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN; and
• Serum creatinine =< 1.2 times the upper limit of normal
• ECOG performance =< 2 at the time of second registration
• Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), promyelocytic leukemia protein [PML]/retinoic acid receptor alpha [RARa] and variants)
• Prior treatment with omacetaxine
• Relapsed or refractory AML
• Investigational agent received within 30 days prior to the first dose of study drug; if received any investigational agent prior to this time point, drug-related toxicities must have recovered to grade 2 or less prior to first dose of study drug
• Psychiatric disorders that would interfere with consent, study participation, or follow-up
• Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
• Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy; this includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine)
• Active carcinoma requiring systemic chemotherapy or radiation therapy