Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

Arms (1)

1. type

   EXPERIMENTAL

   label

   All Study Patients

   description

   * Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4

   interventionNames

   1. Drug: vosaroxin

Primary outcomes (1)

1. measure

   Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions

   timeFrame

   2 years

   description

   Combined remission rate (complete remission \[CR\] + complete remission with incomplete platelet recovery \[CRp\]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts \< 5%, absolute neutrophil count (ANC) \> 1000 cells/uL, and platelet (plt) count \> 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count \<= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.