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
- Diseases
- Acute myeloid leukemia
- 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
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Pessac Cedex | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.