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Study on Early Treatment Intensification for Acute Myeloid Leukemia with FLT3 Mutation Using Cytarabine, Midostaurin, and Daunorubicin Hydrochloride for Patients with Low Chemosensitivity

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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 genetic change known as the FLT3 mutation. The study aims to find the best treatment approach for these patients by using a special marker called peripheral blast clearance (PBC) to tailor the therapy. The trial will compare different treatment plans to see which one helps patients live longer without the disease coming back.

The treatments being tested in this study include several medications. One of the main drugs is cytarabine, which is given as an injection. Another medication used is midostaurin, which comes in the form of a soft capsule taken by mouth. Additionally, daunorubicin hydrochloride is used, which is a powder that is mixed and given through an infusion into a vein. Some patients may also receive a placebo, which looks like the real medication but does not contain any active ingredients.

During the study, participants will receive these treatments over a period of time, with the goal of improving their chances of recovery. The study will monitor how well the treatments work and how safe they are for the patients. By using the PBC marker, the study hopes to identify which treatment plan is most effective for patients with the FLT3 mutation in AML. The results of this study could help doctors better understand how to treat this type of leukemia in the future.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of a FLT3 mutation in acute myeloid leukemia (AML) and ensuring all necessary diagnostic materials are available.

    The assessment also checks for identifiable leukemia cells in the blood and evaluates the immune system's response to the disease.

  2. Step 2

    Treatment induction

    The treatment begins with an induction phase. During this phase, you will receive high doses of medications to reduce leukemia cells.

    The medications include cytarabine administered intravenously, midostaurin taken orally, and daunorubicin hydrochloride given through intravenous infusion.

  3. Step 3

    Peripheral blast clearance measurement

    On day 4 of the treatment, a measurement of peripheral blast clearance (PBC) is conducted. This test helps determine how well the treatment is working by measuring the reduction of leukemia cells in the blood.

  4. Step 4

    Treatment intensification

    Based on the PBC results, the treatment may be intensified. This involves adjusting the medication doses or adding new treatments to improve outcomes.

    The goal is to enhance the effectiveness of the treatment for those with low PBC results.

  5. Step 5

    Consolidation phase

    Following the induction phase, a consolidation phase occurs. This phase aims to eliminate any remaining leukemia cells and prevent relapse.

    During this phase, you may be considered for an allogeneic transplant, which involves receiving healthy stem cells from a donor.

  6. Step 6

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess your response to treatment and manage any side effects.

    Follow-up visits are scheduled to evaluate your health status and ensure the treatment's long-term effectiveness.

Who can join the trial?

8 criteria

  • Patients must have a type of blood cancer called Acute Myeloid Leukemia (AML) that has a specific change in the FLT3 gene.
  • The AML must be newly diagnosed and not previously treated.
  • There must be enough biological material available for detailed testing of the disease.
  • There must be visible cancer cells, called blasts, in the blood at the time of diagnosis.
  • The cancer must show a specific pattern, called Leukemia-associated aberrant immune-phenotype (LAIP), which is checked using a test called multiparametric flow cytometry (MFC).
  • Patients must be between 18 and 65 years old.
  • Patients must have a general health status that is measured by a scale called ECOG performance status, which should be between 0 and 2, or 3 if it can be improved with care.
  • Patients must sign a written consent form agreeing to participate in the study, following international and local laws.

Who cannot join the trial?

7 criteria

  • Patients who do not have **Acute Myeloid Leukemia (AML)** with a **FLT3 mutation** cannot participate. **Acute Myeloid Leukemia** is a type of cancer that affects the blood and bone marrow. **FLT3 mutation** is a specific change in the DNA of the leukemia cells.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not predicted to have low **chemosensitivity** cannot participate. **Chemosensitivity** refers to how well cancer cells respond to chemotherapy.
  • Patients who are not able to undergo the required treatment intensification phases, such as high-dose delivery or allogeneic transplant, cannot participate. **Allogeneic transplant** is a procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. **Vulnerable populations** may include groups like children, pregnant women, or those with certain disabilities.
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Investigated drugs

  • FLT3 Inhibitor

    is a type of medication used in this trial to target a specific mutation found in some acute myeloid leukemia (AML) patients. This medication works by blocking the activity of the FLT3 protein, which is often overactive in these patients. By inhibiting this protein, the medication aims to slow down or stop the growth of cancer cells, helping to improve the patient's condition.

  • High-dose Chemotherapy

    is a treatment approach used in the trial to aggressively target and kill cancer cells. This therapy involves using higher doses of chemotherapy drugs than usual to increase the chances of eliminating cancer cells from the body. The goal is to reduce the number of cancer cells significantly, which can help in achieving remission in patients with AML.

  • Allogeneic Transplant

    is a procedure included in the trial as part of the consolidation phase of treatment. This therapy involves replacing the patient's diseased bone marrow with healthy bone marrow from a donor. The new bone marrow can produce healthy blood cells, which can help restore the patient's immune system and improve their chances of recovery from AML.

What is already known about the treatment

Medication Name – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating Acute Myeloid Leukemia (AML) with a specific genetic mutation known as FLT3. The main therapeutic use of this medication is to improve the survival of patients with this type of leukemia by helping to clear cancer cells from the blood more effectively. At the molecular level, it works by blocking the activity of the FLT3 protein, which is involved in the growth and survival of cancer cells. This medication is classified as a targeted therapy, which means it specifically targets cancer cells with certain characteristics, reducing harm to normal cells.

Investigated diseases

Acute Myeloid Leukemia with FLT3 Mutation – 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. The FLT3 mutation is a genetic alteration found in some AML patients, which can lead to more aggressive disease progression. In AML with FLT3 mutation, the abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses as these abnormal cells continue to multiply and spread, potentially affecting other organs. The presence of the FLT3 mutation often indicates a higher risk of rapid disease progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505901-17-00Protocol codeGIMEMA AML1919Estimated enrolment172 patientsSponsorFondazione Gimema Franco Mandelli Onlus

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