Secondary Acute Myeloid Leukemia (Secondary AML, sAML) Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment