Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML

Inclusion Criteria

• •Subjects with relapsed or refractory AML, except those with APL (acute promyelocytic leukemia), that are about to receive their initial treatment for first relapse after an initial CR that lasted less than 6 months or for primary refractory AML that have an expected complete response rate ≤20%. The initial diagnosis of AML has to be based on the presence of \> 10% blasts in marrow or blood, and the diagnosis of relapsed/refractory AML based on the presence of either \> 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb \< 10 g/dL, or platelets \< 100,000 /uL, or neutrophil count \< 1000 /uL).
• •Peripheral AML blast count \< 50,000 /uL that is not projected to rise above 50,000 /uL within 5 days of beginning treatment.
• •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• •Subjects must be \>18 years old.
• •Male, or female subjects who are post-menopausal (amenorrhagic for at least 12 months), or surgically or biologically sterile. Females of childbearing potential with a negative serum pregnancy test 72-96 hours prior to the 1st infusion in the study and using adequate forms of contraception for the duration of the study, including 30 days after the last treatment. Adequate methods of contraception should be used by both male and female subjects.
• •Subjects must have adequate organ and immune function as indicated by the following laboratory values:
• •* Parameter Laboratory Values
• •* Serum creatinine; \<2.0mg/dL
• •* Total Bilirubin \<2.0mg/dL
• •* AST (SGOT) and ALT (SGPT) \<3 X ULN \* \*ULN: Institution's upper limit of normal.
• •The subject must understand and be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
• •The subject, or the subject's legal guardian, must have given written personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.