At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 666 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in 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 III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy
In Brief
A Phase 3 clinical trial evaluating Placebo, Volasertib, and 1 other intervention for Leukemia, Myeloid, Acute. Completed, enrolled 666 participants across 122 sites in 25 countries.
Detailed Summary
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesArgentina, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Africa, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionAug 2014
Study CompletionMay 2021
TodayJul 2026
First PostedNov 6, 2012
Enrollment StartJan 29, 2013
Primary CompletionAug 12, 2014
Study CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.7 years ago
Interventions
Placebodrug
Placebo matching Volasertib
Volasertibdrug
Volasertib
Cytarabinedrug
Cytarabine