An Open-label Randomized Controlled Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

Inclusion Criteria:

- Diagnosis of AML as defined by the World Health Organization (WHO) classification
(Vardiman 2009)

- Primary refractory AML (defined as a failure to achieve a CR or CRi after therapy
with curative intent) or AML in first relapse

- ECOG Performance status 0, 1 or 2

- Age > 18 and < 70 years

- For patients presenting with primary refractory AML, > 20% blasts on baseline bone
marrow assessment

- For patients presenting with relapsed AML, > 5% blasts on baseline bone marrow
assessment

Exclusion Criteria:

- An initial diagnosis of acute promyelocytic leukemia (as defined by
French-American-British criteria (Bennett 1976))

- Secondary AML, defined as AML evolving from antecedent hematological disorder or
prior exposure to leukemogenic therapy or agent

- Clinically active CNS leukemia

- Previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6
months

- Previously received > 1 induction regimen (Defined as 1 or 2 cycles of a drug or a
drug combination administered as remission induction therapy)