At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 112 enrolled
Drug / intervention
Venetoclax +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.
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
In Brief
A Phase 3 clinical trial evaluating Venetoclax and Azacitidine for Acute Myeloid Leukemia (AML). Completed, enrolled 112 participants across 156 sites in 19 countries.
Detailed Summary
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML)
CountriesAustralia, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Puerto Rico, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsRoche-Genentech
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartMar 2020
Primary CompletionSep 2022
Study CompletionFeb 2026
TodayJul 2026
First PostedSep 25, 2019
Enrollment StartMar 26, 2020
Primary CompletionSep 29, 2022
Study CompletionFeb 20, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.8 years ago
Interventions
Venetoclaxdrug
Tablet: Oral
Azacitidinedrug
Subcutaneous (SC) or intravenous (IV) injection
Azacitidinedrug
Oral Tablet