Study of Pivekimab Sunirine Combined with Venetoclax and Azacitidine in Adults with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy

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What is this study about?

Acute Myeloid Leukemia is a fast‑growing blood cancer that starts in the bone marrow, the spongy tissue inside bones where blood cells are made. In this condition, abnormal cells grow quickly and crowd out normal blood cells, leading to symptoms such as fatigue, easy bruising, and infections. The study tests a combination of three medicines: an antibody called Pivekimab Sunirine (referred to as PVEK), a pill called Venetoclax that is taken oral, and a drug called Azacitidine that is given intravenous or under the skin.

The main goal is to see whether adding PVEK to the standard pair of Venetoclax and Azacitidine can increase the rate of complete remission and help patients live longer, measured as overall survival. Participants will receive the medicines in regular cycles over several months, with clinic visits for dosing, blood tests, and health questionnaires. The study is divided into two parts: an early stage that looks primarily at remission rates, and a later stage that also compares how long patients survive.

Throughout the trial, doctors will watch for side effects and any changes in how the disease behaves. Patients will have routine check‑ups, lab work, and imaging as needed to ensure safety and to track the disease. After the treatment period, follow‑up visits continue for a period to monitor long‑term outcomes and quality of life.

1 initial visit and baseline assessments

after joining the study, you will have an initial visit where medical staff will record your health information, perform physical examinations, and collect blood and bone‑marrow samples to confirm the diagnosis of acute myeloid leukemia.

these baseline measurements are needed to compare later results and to ensure that the study medicines are appropriate for you.

2 start of treatment cycle

the treatment phase begins with three medicines that are taken together according to the study schedule.

venetoclax is an oral tablet (taken by mouth). the exact dose in milligrams is not provided in this summary, but it will be taken each day as directed by the study protocol.

pivekimab sunirine is given by intravenous infusion (through a vein). it is supplied as a powder that is mixed with a liquid and delivered over a set period of time. the specific amount and how often it is infused are defined by the study protocol.

azacitidine is administered as an injection either intravenously or subcutaneously (under the skin). the concentration is expressed as milligrams per millilitre, but the exact dose and frequency are determined by the study schedule.

3 regular dosing schedule

you will continue to take the oral venetoclax tablet each day for the duration of each treatment cycle.

the pivekimab sunirine infusion is repeated on the days specified by the investigators, usually once per cycle, but the exact interval is defined by the protocol.

the azacitidine injection is given on the days outlined in the study plan, often several times within each cycle.

4 monitoring and follow‑up visits

throughout the treatment period you will have regular clinic visits where blood tests, bone‑marrow examinations, and other safety checks are performed to monitor how the medicines are working and to detect any side effects.

any adverse events (unwanted medical problems) are recorded and reported to the study team.

5 continuation of therapy

treatment cycles are repeated until the study determines that therapy should stop, which may be because of disease response, unacceptable side effects, or the predefined end of the study period.

the goal of the combined therapy is to achieve complete remission, meaning that signs of leukemia are no longer detectable, and to improve overall survival.

6 final assessment

at the end of the study you will undergo a final evaluation that includes the same tests performed at baseline to assess disease status and overall health.

results from this assessment help determine the effectiveness of the treatment combination.

Who Can Join the Study?

  • You must have a confirmed diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) guidelines; this means doctors have used standard tests to be sure you have this type of blood cancer.
  • Your white blood cell (WBC) count must be less than 25 × 10⁹ per liter. If it is higher, doctors may give you a medicine called hydroxyurea before the study starts to lower the count to the required level.
  • Your kidneys must work well enough, shown by a creatinine clearance of at least 30 mL per minute. This can be measured using the Cockcroft‑Gault formula (a calculation based on your age, weight, and blood tests) or by collecting all urine you produce in 24 hours and testing it.

Who Cannot Join the Study?

  • If you have certain other blood cancers—such as Acute Promyelocytic Leukemia (APL), the advanced “blast phase” of chronic myeloid leukemia, AML that carries a genetic change called t(9;22) or BCR‑ABL1 fusion, disease that changed from a myeloproliferative neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), an unspecified mixed blood disorder, or a solid tumor of blood‑cell origin called myeloid sarcoma—you cannot take part in this study.
  • If the leukemia is currently affecting your central nervous system (CNS)—meaning it has spread to the brain or spinal fluid—you are not eligible. Having leukemia outside the CNS is allowed, except when the only sign is a myeloid sarcoma.
  • If you have had any other malignancy (cancer) within the past two years, you cannot join, unless it was one of the following low‑risk or fully treated cancers: a very early‑stage (in situ) cancer of the cervix, breast, bladder, or esophagus; a limited skin cancer such as basal cell carcinoma or a small squamous cell carcinoma; or a cancer that was completely removed or otherwise treated with the goal of cure and has not returned in the last two years.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Hospital Universitario De Navarra Pamplona Spain
Medical University Of Graz Graz Austria
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Nice Nice France
Hospital General Universitario Gregorio Maranon Madrid Spain
Ifpwvihc Pvzfqfukexlrnwy Cbirwi Cteanr Marseille France
Cqvmce Hhqtvcwmcnj Rinoyfqq Dficiygkshxmhk Angers France
Csxbff Hlyfwefpjjb Uhzxahmylnxhd Avcmbx Psmytdqz Amiens France
Hvachzfk Uzhzpotxenwxt Pdxezh Di Hmmsqf Dn Makafjdxymy Majadahonda Spain
Mp Ayvnsxro Cxtfde Ccputz Madrid Spain
Hupwfuen Cisora Dm Buxenydra Barcelona Spain
Ijqkaruu Cjibca Dwwvimolhnhihprad L'hospitalet De Llobregat Spain
Vzpcyv dpx Rlwxt Uccavjahiv Hbbrdiaq Sevilla Spain
Ozxzhgscoivkal Lkja Gzol Linz Austria
Hpnxtak Kfxyyvhtrip Dem Wwxcqi Gytmmuhnxqgbtdooopg Vienna Austria
Nfy Lqa Gngdcmgtug Rnfskl Muqhh Gvjb St. Poelten Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.10.2026
France France
Recruiting
01.10.2026
Spain Spain
Recruiting
01.10.2026

Trial locations

Pivekimab Sunirine is an experimental drug given through an IV infusion. In this study it is being tested together with two other medicines to see if it can help newly diagnosed AML patients who cannot receive strong chemotherapy. The goal is to find out whether adding this drug improves the chance of the disease going into complete remission.

Venetoclax is an oral tablet taken by mouth. It works by blocking a protein that helps cancer cells survive, which can make the leukemia cells more likely to die. In the trial it is used together with other medicines to try to increase the number of patients who achieve complete remission and to help them live longer.

Azacitidine is given as an injection. It belongs to a class of drugs that can slow down the growth of cancer cells and help the bone marrow make healthier blood cells. In this study it is combined with the other two drugs to see if the three‑drug combination works better than the standard two‑drug treatment.

Investigated Diseases:

Acute Myeloid Leukemia – Acute Myeloid Leukemia is a cancer of the blood‑forming tissue in the bone marrow. It causes the marrow to produce large numbers of immature white blood cells that do not work properly. These abnormal cells crowd out normal blood cells, leading to low red cells, platelets, and healthy white cells. The disease can spread to the blood and other organs such as the spleen and liver. Over time the buildup of these cells can worsen blood counts and cause symptoms that increase in severity.

Trial ID:
2025-523724-47-00
Protocol code:
M26-092
Trial Phase:
Therapeutic use (Phase IV)

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