A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Exclusion Criteria

• •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
• •Patients with acute promyelocytic leukemia (APML).
• •Major surgery within 4 weeks of study enrollment.
• •Patients with serious pre-existing medical conditions (at the discretion of the investigator). Because of the known cardiac toxicity of anthracyclines, patients with pre-existing ejection fraction (EF) less than or equal to 45% should not participate in this study. No patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120 mg/m²).
• •Patients with a second malignancy that could affect the interpretation of the results.
• •Patients with leukemic involvement of the central nervous system (CNS) by spinal fluid cytology or imaging.
• •Patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. Patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.
• •Concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).
• •Women who are pregnant or breast feeding.
• •Patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.