Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India
← catalyst calendarNCT07044687 · readout ≤ 468 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
100estimated
Sites
13
Country
India
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 | 2025-07-24 | actual | When the study began enrolling |
| Primary completion | Nov 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | 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
Interventions
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Azacitidine
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants with Treatment Emergent Adverse Events (TEAE)s
measured Up to Approximately 29 Months
Percentage of Participants with Post-Baseline Laboratory Abnormalities
measured Up to Approximately 29 Months
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