At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 711 enrolled
Drug / intervention
vosaroxin + cytarabine +1 moredrug
Likely dose
vosaroxin + cytarabine 90 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
In Brief
A Phase 3 clinical trial evaluating vosaroxin + cytarabine and placebo + cytarabine for Acute Myeloid Leukemia. Completed, enrolled 711 participants across 124 sites in 15 countries.
Detailed Summary
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, New Zealand, Poland, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartDec 2010
Primary CompletionSep 2014
Study CompletionMar 2017
TodayJul 2026
First PostedAug 31, 2010
Enrollment StartDec 17, 2010
Primary CompletionSep 26, 2014
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.8 years ago
Interventions
vosaroxin + cytarabinedrug
Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
placebo + cytarabinedrug
Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC)