6,8-Bis(benzylthio)octanoic Acid, Cytarabine, and Daunorubicin Hydrochloride in Treating Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Inclusion Criteria

• Patients must have histologically or cytologically documented newly diagnosed acute myeloid leukemia (non-acute promyelocytic leukemia [APL]) that has not yet been treated; hydroxyurea (Hydrea) and tretinoin (ATRA) previous treatments are acceptable
• Hydroxyurea may be used to control leukocytosis and can be taken until day 1 of therapy; patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade 2 are eligible, but must be documented as such
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 3 and fit for induction therapy in the opinion of the treating physician
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal (=< 5 X upper limit of normal [ULN] if liver metastases present)
• Bilirubin =< 1.5 X ULN
• Creatinine =< 1.5 mg/dL or 133 umol/L
• International normalized ration (INR) < 1.5
• Albumin >= 2.0 g/dL
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria

• Patients who have received any therapy other than hydroxyurea with the purpose of treating their AML are not eligible
• Patients having received prior radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy for a non-AML malignancy within the 2 weeks prior to treatment with CPI-613, or those who have not fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment)
• Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
• Patients with known central nervous system involvement should be excluded from this clinical trial
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CPI-613
• Uncontrolled concurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with large and recurrent pleural or peritoneal effusions requiring frequent drainage (e.g. weekly); patients with any amount of clinically significant pericardial effusion
• Patients with known human immunodeficiency virus (HIV) infection
• A history of additional risk factors for Torsade de Pointes (e.g., clinically significant heart failure, hypokalemia, family history of long QT syndrome)
• Pregnant women are excluded from this study; breastfeeding should be discontinued