A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
443actual
Sites
172
Countries
Australia, Austria, Belgium +26
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-02-02 | actual | When the study began enrolling |
| Primary completion | 2021-12-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-15 | estimated | The whole study's end, after follow-up |
| First posted | 2016-12-15 | estimated | When this record first appeared on the registry |
| Results posted | 2023-01-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acute Myeloid Leukemia (AML)
Interventions
- Drug: Azacitidine
- Drug: Venetoclax — also filed as ABT-199
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFOverall Survival (OS)
measured From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)
Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
measured From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-07-01 · 1.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2020-03-03 · 405 KB · SAP_001.pdf
Publications
- PMID 40913104 — linked by the registry
- PMID 39133921 — linked by the registry
- PMID 36007102 — linked by the registry
- PMID 35829925 — linked by the registry
- PMID 35696071 — linked by the registry
- PMID 35063965 — linked by the registry
- PMID 35046058 — linked by the registry
- PMID 34910556 — linked by the registry
- PMID 32786187 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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