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Study on the Safety of Ivosidenib and Azacitidine for Adults with Newly Diagnosed IDH1m Acute Myeloid Leukemia Not Eligible for Intensive Chemotherapy

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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 type of blood cancer called acute myeloid leukemia (AML), specifically in patients who have a mutation known as IDH1m. The study is designed for adults who have been newly diagnosed with this condition and are not eligible for intensive chemotherapy. The treatment being tested combines two medications: ivosidenib, which is taken as a tablet, and azacitidine, which is given as an injection. The purpose of the study is to learn more about the safety and how well patients can tolerate this combination of treatments.

Participants in the study will receive both medications and will be monitored to see how their bodies respond. The study will look at any side effects that occur, as well as how the treatment affects the cancer. The trial will also gather information on how long patients can go without the cancer getting worse and how long they live overall. This information will help doctors understand if this combination of treatments is a good option for patients with this specific type of AML.

The study will take place over a period of time, during which participants will have regular check-ups and tests to monitor their health and the progress of the treatment. The goal is to ensure that the treatment is safe and to determine the best way to use it in the future for patients with IDH1m acute myeloid leukemia.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    Upon joining the study, you will start the treatment with two medications: azacitidine and ivosidenib. Azacitidine is provided as a powder that is mixed into a liquid for injection, while ivosidenib is given as a film-coated tablet to be taken by mouth.

    The treatment is designed for patients with a specific type of leukemia called IDH1m acute myeloid leukemia (AML), who are not eligible for intensive chemotherapy.

  2. Step 2

    Medication administration

    You will receive azacitidine through an injection. The exact dosage and frequency will be determined by the medical team based on your specific needs and health condition.

    You will take ivosidenib orally in the form of a 250 mg tablet. The frequency and duration of taking this medication will also be guided by the medical team.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, your health will be closely monitored to assess the safety and tolerability of the treatment. This includes regular check-ups and tests to track any side effects or changes in your condition.

    You may be asked to report any symptoms or side effects you experience, as well as any changes in your overall health.

  4. Step 4

    Follow-up visits

    You will have scheduled follow-up visits with the medical team. These visits are important for evaluating your response to the treatment and making any necessary adjustments.

    During these visits, additional tests may be conducted to gather more information about your health and the effectiveness of the treatment.

  5. Step 5

    End of trial

    The trial is expected to continue until December 2026. Your participation may last until the end of the trial or until the medical team decides it is appropriate to conclude your involvement.

    At the end of your participation, a final assessment will be conducted to review your health status and any outcomes from the treatment.

Who can join the trial?

14 criteria

  • The patient must have a specific type of leukemia called Isocitrate dehydrogenase1 mutation-positive (IDH1m) acute myeloid leukemia (AML).
  • The patient must not have received any previous treatment for AML.
  • The patient must be at least 18 years old.
  • The patient must meet at least one of the following conditions that make them unsuitable for intensive chemotherapy (IC):
    • Be 75 years old or older.
    • Have an ECOG performance status of 2, which means they are up and about more than half the day but cannot work.
    • Have a severe heart or lung condition.
    • Have a creatinine clearance (a measure of kidney function) less than 45 mL/minute.
    • Have a bilirubin level more than 1.5 times the normal upper limit, which indicates liver function.
    • Have any other condition that the doctor believes makes intensive chemotherapy unsuitable.
    • The patient must have a confirmed R132 IDH1 mutation based on a local test.
    • The patient must have an ECOG performance status of 2 or less.
    • The patient must have adequate liver function, classified as Child-Pugh class A or B.
    • The patient must have adequate kidney function as described in the study protocol.
    • The patient must be willing to provide written, signed, and dated informed consent voluntarily.

Who cannot join the trial?

10 criteria

  • Patients who do not have a **mutation** (a change in the DNA) in the **isocitrate dehydrogenase 1 (IDH1)** gene.
  • Patients who do not have **acute myeloid leukemia (AML)**, a type of blood cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who have other medical conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study drugs or similar drugs.
  • Patients who have had certain treatments for AML recently.
  • Patients who have certain infections or other serious health issues.
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Investigated drugs

  • Ivosidenib

    is a medication used in this clinical trial to treat a type of blood cancer called acute myeloid leukemia (AML). It works by targeting a specific genetic mutation known as IDH1, which is found in some patients with AML. By blocking the activity of this mutation, ivosidenib helps to stop the growth of cancer cells and can lead to their death. This medication is particularly used for patients who are not able to undergo more intensive chemotherapy treatments.

  • Azacitidine

    is another medication used in this trial alongside ivosidenib. It is a type of chemotherapy that helps to slow down or stop the growth of cancer cells. Azacitidine works by affecting the DNA within the cancer cells, which can help to restore normal function and growth. This medication is often used to treat patients with AML who cannot receive more aggressive forms of chemotherapy, making it a suitable option for those with newly diagnosed cases in this study.

What is already known about the treatment

Ivosidenib – Ivosidenib is administered orally and is currently being studied in combination with azacitidine for treating adults with a specific type of blood cancer called IDH1 mutation-positive acute myeloid leukemia (AML) who cannot undergo intensive chemotherapy. It works by targeting and inhibiting a mutated enzyme called IDH1, which is involved in the growth of cancer cells. Ivosidenib is classified as a targeted cancer therapy, and its main therapeutic use is to treat certain types of leukemia by slowing down or stopping the growth of cancer cells.

Investigated diseases

Isocitrate dehydrogenase 1 mutation-positive acute myeloid leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. It is associated with a specific genetic mutation in the isocitrate dehydrogenase 1 (IDH1) enzyme. The disease begins in the bone marrow, where blood cells are produced, and can quickly spread to the blood and other parts of the body. As the abnormal cells accumulate, they interfere with the production of normal blood cells, leading to symptoms such as fatigue, infections, and bleeding. The progression involves the continuous growth and accumulation of these abnormal cells, which can lead to a decrease in the number of healthy blood cells. Over time, this can result in various complications related to the lack of normal blood cell function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501709-11-00Protocol codeDIM-95031-006Estimated enrolment204 patientsSponsorServier Affaires Medicales

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