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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antisoma Research
• Treatments: Cytarabine

Criteria

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