Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
← catalyst calendarNCT04401748 · readout ≤ 346 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →. With Genentech, Inc..
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
531actual
Sites
220
Countries
Australia, Austria, Belgium +20
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 | 2020-09-10 | actual | When the study began enrolling |
| Primary completion | Jul 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2020-05-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelodysplastic Syndrome (MDS)
Interventions
- Drug: Venetoclax — also filed as ABT-199, GDC-0199, Venclexta
- Drug: Azacitidine — also filed as AZA
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFOverall survival (OS)
measured Up To 5 Years
Publications
- PMID 41792302 — linked by the registry
- PMID 38065202 — 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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