At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 211 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 Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Placebo, Venetoclax, and 1 other intervention for Acute Myeloid Leukemia (AML). Completed, enrolled 211 participants across 109 sites in 24 countries.
Detailed Summary
The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML)
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Ireland, Japan, Mexico, New Zealand, Norway, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartMay 2017
Primary CompletionFeb 2019
Study CompletionAug 2025
TodayJul 2026
First PostedMar 3, 2017
Enrollment StartMay 23, 2017
Primary CompletionFeb 15, 2019
Study CompletionAug 21, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.3 years ago
Interventions
Placebodrug
tablet
Venetoclaxdrug
tablet
Cytarabinedrug
Subcutaneous injection