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NCT07581002RecruitingPhase 2/3

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 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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Aug 2026

Brief summary (registry, in English)

Phase 2: To evaluate if treatment with pivekimab sunirine (PVEK) in combination with venetoclax (VEN) + azacitadine (AZA) improves complete remission (CR) rate as compared to standard of care with VEN + AZA in adult participants with newly diagnosed acute myeloid leukemia (AML) ineligible to receive intensive chemotherapy. Phase 3: To assess the superiority of treatment with PVEK in combination with VEN + AZA in improving CR rate and prolonging overall survival (OS) compared to standard of care VEN + AZA in adult participants with newly diagnosed AML ineligible to receive intensive chemotherapy.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
25 (estimated)
First submitted
9 Apr 2026
Start date
18 Aug 2026
Lead sponsor
AbbVie Deutschland GmbH & Co. KG
EU CT number
2025-523724-47-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 25
  • 21 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known active central nervous system (CNS) involvement with AML. Participants may have non-CNS extramedullary disease (excludes participants with myeloid sarcoma as the only disease manifestation at screening).
  • Participants with history of any malignancies within 2 years prior to screening with exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of the breast, in situ - carcinomas of bladder and esophagus; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, and previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and have no evidence of relapse within 2 years.

Other

  • Acute promyelocytic leukemia (APL), blast phase of CML or AML with t(9;22) or BCR:ABL1 fusion, transformation from myeloproliferative neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), myelodysplastic/myeloproliferative neoplasm unspecified, or myeloid sarcoma.

Who the study is looking for

  • Participants must have confirmation of acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria.
  • White blood cell (WBC) count < 25 × 10^9/L (hydroxyurea is permitted prior to beginning study treatment to reduce the WBC count to < 25 × 10^9/L).
  • Adequate renal function as demonstrated by a creatinine clearance >= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaRecruiting
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
MD Anderson Cancer Center
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Centre Hospitalier Universitaire De Bordeaux
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Pessac CedexFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.