A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

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

This is 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)