Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
- Conditions
- Leukemia, Myeloid
- Registration Number
- NCT00512083
- Lead Sponsor
- Antisoma Research
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Univeristy of Colorado Health Cancer Center
🇺🇸Aurora, Colorado, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Cancer Therapy and Research Center - Institute for Drug development
🇺🇸San Antonio, Texas, United States
Christchurch Hospital
🇳🇿Christchurch, New Zealand
St. Francis Hospital and Health Center
🇺🇸Beech Grove, Indiana, United States
University of Louisville, James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Washington University
🇺🇸St Louis, Missouri, United States