A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
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Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
465actual
Sites
165
Countries
Australia, Brazil, Canada +15
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
Why the sponsor stopped it
Strategic considerations
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-02-26 | actual | When the study began enrolling |
| Primary completion | 2025-09-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-23 | actual | The whole study's end, after follow-up |
| First posted | 2019-11-13 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-04 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Myeloid Leukemia (AML)
- Cancer
Interventions
- Drug: Venetoclax — also filed as ABT-199, GDC-0199, VENCLEXTA
- Drug: Azacitidine
- Other: Best Supportive Care (BSC)
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
measured Up to 28 days
Overall Survival (OS) (Part 2)
measured Up to approximately 41 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-04-08 · 3.0 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-11-16 · 507 KB · SAP_001.pdf
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