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Study on Improving Survival in Acute Myeloid Leukemia for Adults Aged 18-60 Using Idarubicin, Daunorubicin, Cytarabine, and Mycophenolic Acid

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 Acute Myeloid Leukemia (AML) in adults aged 18 to 60. The study aims to improve the overall survival of patients with this type of blood cancer. The trial involves comparing different treatments to find the most effective approach. One part of the study compares two chemotherapy drugs, idarubicin and daunorubicin, which are used during the initial phase of treatment. Another part of the study looks at different doses of cytarabine, a chemotherapy drug, to see which dose works best after the initial treatment phase.

Additionally, the study includes a comparison of a combination of cytarabine and venetoclax, a medication that helps to kill cancer cells by targeting a specific protein. The purpose of this combination is to see if it can help patients stay free of leukemia for a longer period. The trial also examines the use of mycophenolic acid as a standard preventive treatment to reduce the risk of a condition called graft versus host disease (GvHD), which can occur after a stem cell transplant.

Participants in the study will receive one of the treatment combinations and will be monitored over time to assess their response to the treatment. The study will help determine which treatment options provide the best outcomes for patients with Acute Myeloid Leukemia. The trial is expected to continue until 2025, with the goal of improving treatment strategies for this challenging disease.

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

    Joining the trial

    Upon joining the trial, you will be required to read and understand the information provided about the study. You must sign an informed consent form to confirm your participation.

  2. Step 2

    Initial treatment phase

    The trial begins with an induction phase where you will receive either idarubicin or daunorubicin. These medications are used to treat acute myeloid leukemia (AML).

    The specific medication and dosage will be determined by random selection. This phase aims to improve overall survival rates.

  3. Step 3

    Post-induction treatment

    After the initial treatment, you will enter the consolidation phase. During this phase, you will receive cytarabine at either a high dose of 3.0 g/m² or an intermediate dose of 1.5 g/m².

    This phase is designed to further reduce leukemia cells and improve long-term outcomes.

  4. Step 4

    Venetoclax combination

    If you are eligible, you may be randomized to receive a combination of cytarabine and venetoclax. Venetoclax is administered orally in the form of film-coated tablets.

    This combination aims to enhance the effectiveness of the treatment and is part of the ongoing research to improve leukemia-free survival.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, your health and response to the treatment will be closely monitored. Regular check-ups and tests will be conducted to assess your condition and any side effects.

    The trial aims to evaluate overall survival at 3 years and leukemia-free survival at 18 months.

Who can join the trial?

11 criteria

  • Patients must be aged 18 and over but under 61 years old.
  • Patients must have been diagnosed with acute myeloid leukemia (AML), which can be either new (de novo) or developed after a condition called myelodysplastic syndrome (MDS) or after cancer treatment (therapy-related AML).
  • Patients should not have received previous treatment for AML, except for a medication called hydroxyurea, or for MDS, except with erythropoietin (EPO).
  • Patients must be in good general health, with an ECOG performance scale of 3 or less. This scale measures how well a patient can perform daily activities.
  • Patients should not have any severe uncontrolled infections.
  • Patients should not have heart problems that prevent the use of a type of drug called anthracyclines. This includes issues like uncontrolled heart disease, recent heart attack, or heart failure.
  • Certain blood tests must be within specific limits: AST and ALAT (liver enzymes) should be no more than 2.5 times the normal limit, total bilirubin should be no more than 2 times the normal limit, and creatinine should be less than 150 micromoles per liter, unless these are due to leukemia.
  • Patients must be tested for FLT3 gene mutations in a laboratory.
  • Patients must use an effective method of contraception. Women of childbearing potential should continue using contraception during treatment and for 5 months after stopping treatment. Men should use condoms during treatment and for 5 months after stopping treatment.
  • Patients must be part of a social security scheme.
  • Patients must have read and understood the information provided and signed the informed consent form.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides acute myeloid leukemia cannot participate. Acute myeloid leukemia is a type of blood cancer.
  • Patients who are younger than 18 or older than 60 years old are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who have had a different treatment for leukemia in the past may not be eligible.
  • Patients with severe heart problems cannot participate.
  • Patients with uncontrolled infections are not eligible.
  • Patients with severe liver or kidney disease cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.
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Investigated drugs

  • Idarubicin

    is a medication used in this trial to treat acute myeloid leukemia (AML). It is part of a group of drugs known as anthracyclines, which work by interfering with the DNA inside cancer cells, preventing them from growing and multiplying. In this study, idarubicin is being compared to another similar drug to see which one is more effective in helping patients live longer.

  • Daunorubicin

    is another medication used in the trial for treating AML. Like idarubicin, it belongs to the anthracycline family and works by disrupting the DNA of cancer cells, stopping their growth. The trial aims to determine whether daunorubicin or idarubicin is better at improving patient survival rates.

  • Cytarabine

    is a chemotherapy drug used in this study to help eliminate cancer cells in patients with AML. It works by interfering with the DNA of the cancer cells, which stops them from dividing and growing. The trial is comparing different doses of cytarabine to find out which dose is more effective in treating the disease.

  • Mycophenolic Acid

    is used in the trial as a standard treatment to prevent a condition called graft versus host disease (GvHD) in patients who have received a stem cell transplant. GvHD can occur when the transplanted cells attack the patient's own body. Mycophenolic acid helps to suppress the immune system, reducing the risk of this condition.

What is already known about the treatment

  • Idarubicin

    Idarubicin is administered intravenously, meaning it is given directly into a vein through an injection. It is currently used in medicine to treat acute myeloid leukemia (AML) in adults aged 18 to 60. The medication works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. It belongs to a class of drugs known as anthracyclines, which are a type of chemotherapy.

  • Daunorubicin

    Daunorubicin is also given intravenously, allowing it to enter the bloodstream directly. It is used in the treatment of acute myeloid leukemia (AML) in adults aged 18 to 60. This medication targets cancer cells by disrupting their DNA, which stops them from multiplying. Daunorubicin is part of the anthracycline class of chemotherapy drugs.

  • Cytarabine

    Cytarabine is administered through an intravenous injection, delivering the drug directly into the bloodstream. It is used to treat acute myeloid leukemia (AML) in adults aged 18 to 60. The drug works by interfering with the DNA of cancer cells, hindering their ability to grow and divide. Cytarabine is classified as an antimetabolite, a type of chemotherapy that targets cell division.

  • Mycophenolic Acid

    Mycophenolic acid is taken orally in pill form. It is used as a standard preventive treatment to reduce the risk of graft versus host disease (GvHD) in patients who have received a stem cell transplant. The medication works by suppressing the immune system, preventing it from attacking the transplanted cells. It is classified as an immunosuppressant.

Investigated diseases

Acute myeloid leukemia – Acute myeloid leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression requires prompt medical attention to manage the symptoms and complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516873-57-00Protocol codeBIG-1Estimated enrolment3 100 patientsSponsorCentre Hospitalier Universitaire D'Angers

sourced from the EU Clinical Trials Register and site verification

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