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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdiagnozowana, nieleczona ostra białaczka szpikowa (AML), która nie jest agresywna.
- •Komórki białaczki mają specyficzny marker (CD123-dodatni).
- •Pacjent nie może przyjmować intensywnej chemioterapii z powodu wieku (powyżej 75 lat) lub innych problemów zdrowotnych.
- •Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (współczynnik ECOG 0-3).
✗ Disqualifies
- •Nieprawidłowe wyniki badań nerek lub wątroby.
- •Wysoka liczba białych krwinek (powyżej 25 × 10^9/L), chyba że zostanie obniżona przed rozpoczęciem leczenia.
- •Wcześniejsze leczenie, które mogłoby wpłynąć na wyniki badania.
- •Ciężkie problemy z sercem lub płucami.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (36)
City of Hope National Medical Center /ID# 279568
Duarte, United States
Moffitt Cancer Center /ID# 279192
Tampa, United States
Winship Cancer Institute of Emory University /ID# 279006
Atlanta, United States
Washington University /ID# 280295
St Louis, United States
Montefiore Medical Center - Moses Campus /ID# 279399
The Bronx, United States
The University of Texas MD Anderson Cancer Center /ID# 279402
Houston, United States
Universitaetsklinikum St. Poelten /ID# 278835
Sankt Pölten, Austria
Hanusch-Krankenhaus /ID# 279467
Vienna, Austria
Medizinische Universitaet Graz /ID# 278830
Graz, Austria
Ordensklinikum Linz Elisabethinen /ID# 278824
Linz, Austria
Medizinische Universitaet Wien /ID# 278825
Vienna, Austria
Institut Paoli-Calmettes /ID# 279015
Marseille, France
Centre Hospitalier Universitaire de Bordeaux /ID# 279001
Pessac, France
Centre Hospitalier Universitaire D'Angers /ID# 280390
Angers, France
CHU Amiens-Picardie Site Sud /ID# 280716
Amiens, France
Rabin Medical Center /ID# 278714
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center /ID# 278717
Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 278719
Haifa, Israel
Shaare Zedek Medical Center /ID# 278712
Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 278866
Jerusalem, Israel
Seoul National University Bundang Hospital /ID# 279634
Seongnam-si, South Korea
Seoul National University Hospital /ID# 279396
Seoul, South Korea
Yonsei University Health System Severance Hospital /ID# 279933
Seoul, South Korea
Asan Medical Center /ID# 279395
Seoul, South Korea
Samsung Medical Center /ID# 279397
Seoul, South Korea
Hospital Universitario Puerta De Hierro /ID# 279660
Majadahonda, Spain
Clinica Universidad de Navarra - Pamplona /ID# 279516
Pamplona, Spain
Hospital Universitario Virgen del Rocio /ID# 279471
Seville, Spain
Hospital General Universitario Gregorio Maranon /ID# 279479
Madrid, Spain
Md Anderson Cancer Center /ID# 279480
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 279635
Valencia, Spain
China Medical University Hospital /ID# 279261
Taichung, Taiwan
Taichung Veterans General Hospital /ID# 279296
Taichung, Taiwan
National Taiwan University Hospital /ID# 279289
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 281480
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 279294
Taoyuan City, Taiwan
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
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