Conditions: Leukemia Acute Disease Acute Myeloid Leukemia Nonlymphocytic Leukemia Myelodysplastic Syndromes
Keywords: Leukemia Myeloid Elderly Hematologic Blood Cancer Malignancy SNS-595 Sunesis Hematologic Diseases Myelodysplastic Syndromes Older voreloxin reveal-1
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 113
Healthy volunteers: no

Brief summary:
This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Detailed description:
Other objectives of this study include:

1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Arms:
arm 1: * 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

Interventions: intervention 1: vosaroxin
Intervention descriptions: intervention 1: Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.

Protocol document: