A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)
← catalyst calendarNCT07581002 · readout ≤ 2,112 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
660estimated
Sites
12
Countries
Israel, South Korea, Taiwan +1
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 | 2026-06-30 | actual | When the study began enrolling |
| Primary completion | May 2032 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-12 | 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: Pivekimab Sunirine
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Matching Placebo for PVEK
Primary outcomes
what the primary-completion date above is the date OFPhase 2: Complete remission (CR)
measured Up to Approximately 71 Months
Phase 3: Complete remission (CR)
measured Up to Approximately 71 Months
Phase 3: Overall Survival (OS)
measured Up to Approximately 71 Months
Number of Participants with Adverse Events (AEs)
measured Up to approximately 71 months
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