Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

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

The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

Inclusion Criteria:

• primary refractory or relapsed AML
• confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
• aged at least 18 years

Exclusion Criteria:

• initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
• patient in blast crisis stage of chronic myeloid leukemia
• received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months
• interval of <6 months between first onset of last complete remission and current relapse
• those with primary refractory leukemia who have received more than three previous induction cycles
• relapsed patients who have received more than three previous treatment regimens