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Trials
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)

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)

A phase 2/3 trial of Pivekimab sunirine, Venetoclax and Azacitidine in acute myeloid leukaemia, run by AbbVie, now recruiting.

Recruiting

Also called: REVIVAL

Overview Taking part Connected10

Overview

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) is a phase 2/3 interventional study registered as NCT07581002 by AbbVie, with 660 participants planned, started 2026-06-30 and due to reach its primary completion in 2032-06. Interventions recorded: Pivekimab Sunirine, Venetoclax, Azacitidine and Matching Placebo for PVEK.

Setting

A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Phase

Phase 2/3

Sponsor

AbbVie

Registry

Started

2026-06-30

Enrolled

660 enrolled

Taking part

NCT07581002recruiting

Run by: AbbVie
Open to: 18 Years and over, any sex
Enrolment: 660 (estimated)
Sites: 36, 36 recruiting
Countries: Austria, France, Israel, South Korea, Spain, Taiwan, United States
Registry updated: 2026-10-02

The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.

ClinicalTrials.gov data courtesy of the US National Library of Medicine.

Connected

10

Similar pages

Trial
IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia
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Trial
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Shares BCL-2 inhibitors, Azacitidine, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax and the tag pipeline.
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A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
Shares BCL-2 inhibitors, Azacitidine, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax and the tag pipeline.
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Shares BCL-2 inhibitors, Azacitidine, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax and the tag pipeline.
Trial
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Shares BCL-2 inhibitors, Azacitidine, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax and the tag pipeline.

cancers

Acute myeloid leukaemia

technologies

Antibody-drug conjugate (ADC)BCL-2 inhibitors Cytotoxic chemotherapy Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule hypomethylating agent (cytotoxic)

Azacitidine · Vidaza / Onureg (oral)

ApprovedADC (anti-CD123 antibody, IGN payload)

Pivekimab sunirine · Decnupaz

ApprovedSmall-molecule BCL-2 inhibitor

Venetoclax · Venclexta

companies

AbbVie (incl. ImmunoGen, Capstan)

Evidence strength41/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2/3+22
660 enrolled+14
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

Make correction

Report a readout

Cancers

Acute myeloid leukaemia

Technologies

Antibody-drug conjugate (ADC)
BCL-2 inhibitors
Cytotoxic chemotherapy
Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)
Small-molecule kinase inhibitors

Products

Pivekimab sunirine
Venetoclax
Azacitidine

Companies

AbbVie (incl. ImmunoGen, Capstan)

Sources

Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.

ClinicalTrials.gov · 1

ClinicalTrials.gov NCT07581002

A source that has moved or gone is reported by the weekly link check. /audit/

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sourced, not expert-reviewed

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