Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China
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Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
44actual
Sites
18
Country
China
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 | 2022-01-06 | actual | When the study began enrolling |
| Primary completion | Mar 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2021-12-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acute Myeloid Leukemia (AML)
Interventions
- Drug: Venetoclax — also filed as ABT-199, GDC-0199, Venclexta
- Drug: Azacitidine
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
measured Up to Approximately 19 Months
Number of Laboratory Abnormalities from Clinical Laboratory Values (Hematology and Chemistry)
measured Up to Approximately 19 Months
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