High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients with Relapsed or Refractory Acute Leukemia

Inclusion Criteria

• Diagnosis of acute leukemia by World Health Organization (WHO) criteria (e.g.-acute myeloid leukemia, acute lymphoblastic leukemia, acute leukemia of ambiguous origin)
• Either: * Relapsed after or refractory to prior treatment with at least two regimens or lines of treatment * Prior failure of at least one regimen or line of treatment, with poor cytogenetic or other risk factors, and ineligible for other clinical trials
• Eastern Cooperative Oncology Group (ECOG) performance status 0 – 3
• Expectation that we can obtain about 10 million blasts from blood and/or marrow (e.g., circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts)
• Bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is thought to be due to Gilbert’s syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SPGT) (alanine aminotransferase [ALT]) =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
• Alkaline phosphatase =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
• Serum creatinine =< 2.0 mg/dL
• Informed consent
• Willing to use contraception when appropriate
• Expected survival is greater than 100 days

Exclusion Criteria

• No other active cancer that requires systemic chemotherapy or radiation
• Active systemic fungal, bacterial, viral or other infection, unless disease is under treatment with antimicrobials and considered controlled in the opinion of the investigator
• Significant organ compromise that will increase risk of toxicity or mortality
• Pregnancy or lactation