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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

3 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Venetoclax

    This medication is taken as an oral film‑coated tablet. It is an approved drug that is widely studied in medical literature for treating certain blood cancers, including acute myeloid leukemia (AML) when used with other agents. Venetoclax works by blocking the BCL‑2 protein, which helps cancer cells survive, thereby allowing the cells to die. It is classified as a BCL‑2 inhibitor, a type of targeted therapy.

  • Pivekimab Sunirine

    This drug is given as a powder that is mixed and infused intravenously. It is currently an investigational medicine being evaluated in clinical trials for AML in combination with venetoclax and azacitidine. Pivekimab Sunirine is a bispecific antibody that attaches to a marker on leukemia cells and to T‑cells, directing the immune system to attack the cancer. It belongs to the bispecific T‑cell engager (BiTE) class of immunotherapies.

  • Azacitidine

    Azacitidine is administered by injection, either under the skin or into a vein. It is an approved and well‑documented treatment for myelodysplastic syndromes and AML in patients who cannot receive intensive chemotherapy. The drug adds a small chemical group to DNA, which turns off genes that allow cancer cells to grow unchecked. It is classified as a hypomethylating agent, a form of chemotherapy.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-523724-47-00Protocol codeM26-092Estimated enrolment90 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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