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Study of Cusatuzumab and Azacitidine for Patients with Newly Diagnosed Acute Myeloid Leukemia Not Eligible 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

This clinical trial is focused on studying a treatment for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study involves two medications: Cusatuzumab and Azacitidine. Cusatuzumab, also known by its code name ARGX-110, is a type of protein-based medication, while Azacitidine is a chemical-based medication available in two forms: a powder for injection and a suspension for injection. The purpose of the study is to determine how effective the combination of Cusatuzumab and Azacitidine is in treating patients with newly diagnosed AML who are not suitable candidates for intensive chemotherapy.

Participants in the study will receive the treatment over a period of up to eight months. The medications will be administered through injections, with Cusatuzumab given intravenously, meaning directly into a vein, and Azacitidine given either intravenously or subcutaneously, which means under the skin. The study aims to observe the response of the leukemia to this treatment combination and to monitor the safety and any side effects experienced by the participants.

This trial is particularly aimed at patients who have not received previous treatment for their AML and are not eligible for more aggressive forms of chemotherapy. The study will help to understand if this combination of medications can provide a beneficial treatment option for these patients. The results will contribute to the knowledge of how these drugs work together and their potential role in managing AML.

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

    Joining the study

    Upon joining the study, the patient will be informed about the purpose and procedures of the trial. The patient must provide informed consent, indicating understanding and willingness to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of acute myeloid leukemia (AML) and ensuring the patient is not a candidate for intensive chemotherapy.

  3. Step 3

    Treatment initiation

    The treatment involves the administration of two medications: cusatuzumab and azacitidine.

    Cusatuzumab is given through an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    Azacitidine is administered subcutaneously. The dosage and frequency will also follow the study protocol.

  4. Step 4

    Treatment duration

    The treatment will continue for a specified duration as outlined in the study protocol. Regular monitoring will occur to assess the patient's response to the treatment.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, the patient will undergo regular monitoring to evaluate the effectiveness of the treatment and to identify any side effects.

    This includes blood tests and other assessments as required by the study protocol.

  6. Step 6

    Completion of study

    Upon completion of the treatment period, the patient will have a final assessment to determine the overall response to the treatment.

    The study aims to evaluate the complete response rate and other outcomes related to the treatment of AML.

Who can join the trial?

16 criteria

  • Must be at least 18 years old.
  • Must sign a form to show they understand the study and agree to participate.
  • Must have **Acute Myeloid Leukemia (AML)**, a type of blood cancer, and meet certain conditions that make them not suitable for strong chemotherapy. This includes:
    • Being 75 years or older, or
    • Being under 75 with certain health issues like:
      • **ECOG Performance Status** of 2, which means they can do some activities but not work.
      • Severe heart problems like heart failure.
      • Severe lung problems affecting breathing.
      • Moderate liver problems.
      • Kidney problems with low creatinine clearance.
      • Other health issues that make strong chemotherapy unsuitable, as decided by the study doctor.
      • Must have either newly diagnosed or secondary AML.
      • Must not have received treatment for AML, except for certain emergency treatments that must be stopped at least 24 hours before the study starts.
      • Must not be eligible for a stem cell transplant.
      • Must have an **ECOG Performance Status** score of 0, 1, or 2, indicating their level of daily activity.
      • Must have certain lab test results within specific limits, such as liver and kidney function tests.
      • If a woman, must either be unable to have children or use effective birth control during the study and for 3 months after. Must have a negative pregnancy test before starting the study.
      • If a man, must use birth control if sexually active with a woman who can have children, and must not donate sperm or plan to father a child during the study and for 3 months after.
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Investigated drugs

  • Cusatuzumab

    is an investigational medication being studied for its potential to treat acute myeloid leukemia (AML). It is designed to target and bind to a specific protein on the surface of certain cancer cells, which may help the immune system to identify and destroy these cells. In this trial, cusatuzumab is being tested in combination with another medication to see if it can improve treatment outcomes for patients with AML who cannot undergo intensive chemotherapy.

  • Azacitidine

    is a medication used to treat certain types of blood cancers, including acute myeloid leukemia (AML). It works by interfering with the growth of cancer cells, which can slow down or stop their spread. In this study, azacitidine is used in combination with cusatuzumab to evaluate if the combination is more effective than azacitidine alone in treating patients with AML who are not candidates for intensive chemotherapy.

What is already known about the treatment

  • Cusatuzumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating acute myeloid leukemia (AML) in patients who cannot undergo intensive chemotherapy. It is an investigational drug, meaning it is not yet approved for general medical use. Cusatuzumab works by targeting a specific protein on leukemia cells, helping the immune system to recognize and destroy these cancerous cells. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with specific pathways in cancer cells.

  • Azacitidine

    This medication is given either as an injection under the skin or through an intravenous infusion. It is an established treatment for certain blood disorders, including acute myeloid leukemia (AML), and is used in patients who are not candidates for intensive chemotherapy. Azacitidine works by incorporating into the DNA of cancer cells, disrupting their growth and leading to cell death. It is classified as a hypomethylating agent, which helps to restore normal function to genes that control cell growth.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease progresses quickly and requires prompt medical attention. It is more common in older adults but can occur at any age. The exact cause of AML is not fully understood, but it involves genetic mutations in the blood-forming cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513283-26-00Protocol codeCULM20236Estimated enrolment65 patientsSponsorOncoverity Inc.

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