Leukemia, Myeloid
Conditions
Keywords
Leukemia, Myeloid + Acute Disease
Brief 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).
Interventions
DRUGAS1411
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
Sponsors
Antisoma Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group | — |
Countries
New Zealand, United States
Outcome results
None listed