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

Antisoma Research

Status and phase

Completed

Phase 2

Conditions

Leukemia, Myeloid

Treatments

Drug: AS1411

Study type

Interventional

Funder types

Industry

Identifiers

NCT00512083

AS1411-C-201

Details and patient eligibility

About

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).

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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