Research and Clinical Trials

Brief Description  
This study is being done to find out how effective and safe Vosaroxin in combination with Cytarabine is compared with using Cytarabine without Vosaroxin. The study will determine if survival is different between the two treatment groups. In this study, vosaroxin or placebo will be administered in a blinded manner as a short IV infusion within 10 minutes on days 1 and 4 of each cycle (up to 4 cycles) and cytarabine will be administered in an unblinded manner as a 2-hour infusion on days 1-5 o
Who may be Eligible  
Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification. Relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the following criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO). Refractory to or relapsed more than 90 days after any induction or consolidation therapy. Patient must not have received greater than 5 g/m2 CUMULATIVE dose of cytarabine (No more than 2 cycles of induction therapy for AML).
IRB Number  
Principal Investigator  
Miller, David

For More Information, Contact  Sandra  , Mizzi
Phone:  (704) 355-7430  Fax:  (704) 355-1188  
Address:1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204