A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →. With Genentech, Inc..
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
134actual
Sites
37
Countries
Australia, Canada, France +4
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 | 2017-01-12 | actual | When the study began enrolling |
| Primary completion | 2026-04-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-15 | actual | The whole study's end, after follow-up |
| First posted | 2016-10-24 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Myelodysplastic Syndromes (MDS)
Interventions
- Drug: Azacitidine
- Drug: Venetoclax — also filed as ABT-199, GDC-0199, VENCLEXTA
Primary outcomes
what the primary-completion date above is the date OFAUCt for Azacitidine
measured Up to 32 days
Cmax of venetoclax
measured Up to 32 days
AUCt for venetoclax
measured Up to 32 days
Tmax of venetoclax
measured Up to 32 days
AUC[0 to infinity] for azacitidine
measured Up to 32 days
Recommended Phase 2 dose (RPTD) and dosing schedule of venetoclax in combination with azacitidine
measured Measured from Day 1 until Day 28 per dose level.
Half-life (t[1/2]) for azacitidine
measured Up to 32 days
Cmax for azacitidine
measured Up to 32 days
AUC[0-24] for venetoclax
measured Up to 32 days
Clearance (CL) for azacitidine
measured Up to 32 days
Tmax for azacitidine
measured Up to 32 days
Complete Remission (CR) Rate
measured Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Publications
- PMID 39652823 — 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.
Permalink · ABBV's whole pipeline · Catalyst calendar · Every registered study · What changed