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

Completed · Phase 2

Conditions studied: Leukemia, Myeloid

In brief

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).

Key facts

Study ID

NCT00512083

Run by

Antisoma Research

People needed

70

Starts

2007-07-01

Last updated by the study team

2009-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Univeristy of Colorado Health Cancer Center — Aurora, Colorado, United States
• St. Francis Hospital and Health Center — Beech Grove, Indiana, United States
• University of Louisville, James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Cancer Therapy and Research Center - Institute for Drug development — San Antonio, Texas, United States
• Christchurch Hospital — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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