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Study identifier: NCT07581002 Synced from ClinicalTrials.gov · July 31, 2026
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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)

Condition: Acute Myeloid Leukemia  ·  Sponsor: AbbVie

PhasePhase 2/Phase 3
Planned participants660
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy. Pivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2/Phase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide. In Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an …

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (11)

Mayo Clinic Hospital - Phoenix /ID# 282904Phoenix, Arizona, United StatesNot Yet Recruiting
City of Hope National Medical Center /ID# 279568Duarte, California, United StatesRecruiting
Mayo Clinic Hospital Jacksonville /ID# 282903Jacksonville, Florida, United StatesNot Yet Recruiting
Montefiore Medical Center - Moses Campus /ID# 279399The Bronx, New York, United StatesRecruiting
Tel Aviv Sourasky Medical Center /ID# 278717Tel Aviv, Tel Aviv, IsraelRecruiting
Rambam Health Care Campus- Haifa /ID# 278719Haifa, IsraelRecruiting
Shaare Zedek Medical Center /ID# 278712Jerusalem, IsraelRecruiting
Hadassah Medical Center-Hebrew University /ID# 278866Jerusalem, IsraelRecruiting
Samsung Medical Center /ID# 279397Seoul, Seoul Teugbyeolsi, South KoreaRecruiting
China Medical University Hospital /ID# 279261Taichung, TaiwanRecruiting
Taichung Veterans General Hospital /ID# 279296Taichung, TaiwanRecruiting

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Source record: clinicaltrials.gov/study/NCT07581002