NCT00715637

Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Antisoma Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

Conditions

• Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

Interventions

Type	Name	Description
DRUG	Daunorubicin and Cytarabine	Daunorubicin: 45 mg/m2 over 30 minutes daily on days 1-3 (up to max. of 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on days 1-7 (up to max. of 2 courses)
DRUG	Amonafide and Cytarabine	Amonafide: 600 mg/m2 IV over 4 hours daily on Days 1-5 (up to max. 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on Days 1-7 (up to max. 2 courses)

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-06-01
• First posted: 2008-07-15
• Last updated: 2010-10-13

Locations

158 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, Ecuador, Estonia, France, Germany, Hungary, Israel, Italy, Poland, Romania, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom