Brentuximab Vedotin, Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients with Relapsed or Refractory CD30 Positive Acute Myeloid Leukemia

Inclusion Criteria

• Pathologically confirmed, relapsed or refractory acute myelogenous leukemia
• CD30 expressing acute myeloid leukemia (AML), as identified by flow cytometric analysis, or by immunohistochemistry when 2+ or 3+ staining is present in greater than or equal to 20% of the myeloblasts in the bone marrow specimen
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit normal (ULN)
• Alkaline phosphatase < 5 x ULN
• Total bilirubin =< 3.0 mg/dl
• Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Left ventricular ejection fraction (LVEF) must be equal to or greater than 50%, as measured by multi gated acquisition (MUGA) scan or echocardiogram
• Patients, or appropriate designee, must be able to provide informed consent
• Must not have received systemic antineoplastic therapy, including radiotherapy within 7 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
• Female patients of childbearing age must have negative urine or serum pregnancy test; subjects agree to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of brentuximab vedotin
• Male subject agrees to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of brentuximab vedotin

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia
• Individuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
• Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy
• Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) =< 50%
• Uncontrolled intercurrent illness that would limit compliance with study requirements
• Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy are ineligible; HIV testing is required only for patients deemed to be high-risk
• A diagnosis of active hepatitis B or C
• Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF < 50%, as measured by MUGA scan or echocardiogram)
• Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome
• Systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection
• Pregnant women are excluded from this study
• Patients deemed to have severe renal impairment should not be considered for this study; patients with creatinine clearance (CrCl) of < 40 mL/min should be excluded
• Patients deemed to have mild hepatic impairment should not be considered for this study; patients with a direct bilirubin level greater than 2.0 mg/dL at screening should be excluded