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Vosaroxin + Cytarabine in Relapsed/Refractory AML
NCT01191801Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2010
- Primary completion
- Sep 2014
- Countries
- 15
- Modality
- DNA Intercalators/Alkylators
- Drugs
- vosaroxin
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 3, randomised, double-blind trial in acute myeloid leukemia (AML) comparing Group A: vosaroxin + cytarabine with Group B: placebo + cytarabine (2 arms). Primary endpoint: Overall Survival up to 5 years. Started Dec 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Group A: vosaroxin + cytarabine
Vosaroxin + Cytarabine
Group B: placebo + cytarabine
Placebo + Cytarabine
03
Who it enrols
Patients >= 18 years with first relapsed or refractory AML, ECOG 0-2, adequate organ function. Excludes APL, >2 prior induction cycles, recent HSCT, or active CNS leukemia.
04
Endpoints
Primary
Overall Survival
Secondary
Complete Remission Rate
All Cause Mortality
05
Results
Primary endpoints met
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