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Study on the Effectiveness of Gilteritinib and Drug Combination for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Fast replyRegistered 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 treatments for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study aims to compare the benefits of low-intensity therapy with high-dose chemotherapy in patients whose disease has returned or is not responding to treatment. The trial will involve several medications, including Gemtuzumab Ozogamicin, Gilteritinib, Venetoclax, Glasdegib, Decitabine, Azacitidine, Cladribine, Ivosidenib, Cytarabine, Amsacrine, Mitoxantrone Hydrochloride, Daunorubicin Hydrochloride, Idarubicin Hydrochloride, Fludarabine Phosphate, and Etoposide. Some of these medications are given by injection or infusion, while others are taken orally.

The purpose of the study is to determine which treatment approach provides better outcomes for patients with AML. Participants will be randomly assigned to receive either low-intensity therapy or high-dose chemotherapy. The study will monitor the time it takes for the disease to progress or for any complications to arise, as well as overall survival rates and response to treatment. Patients will also report on their quality of life during the study.

The trial will last several years, with an estimated end date in 2028. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments. The study will also track any side effects experienced by participants. This information will help doctors understand which treatment options may be most beneficial for patients with AML in the future.

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

    Randomization

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either low intensity therapy or high dose chemotherapy.

  2. Step 2

    Treatment initiation

    Once assigned to a treatment group, you will begin receiving the medications specific to that group. The medications may include cytarabine, amsacrine, gemtuzumab ozogamicin, mitoxantrone hydrochloride, daunorubicin hydrochloride, gilteritinib, venetoclax, glasdegib, decitabine, idarubicin hydrochloride, fludarabine phosphate, azacitidine, etoposide, cladribine, and ivosidenib.

    The administration of these medications will be through various methods such as injection, intravenous infusion (a drip into a vein), or oral (by mouth). The specific dosage, frequency, and duration will be determined by the study protocol and your healthcare provider.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This includes physical examinations, blood tests, and other necessary evaluations.

    You will be asked to complete questionnaires, such as the Hematologic Malignancy–Patient-Reported Outcome (HM-PRO), to provide information on your health and well-being.

  4. Step 4

    End of treatment

    At the end of the treatment period, a final assessment will be conducted to determine the outcome of the therapy. This will include a review of your overall health, any side effects experienced, and the effectiveness of the treatment.

    The primary goal is to measure event-free survival, which is the time from the start of the treatment to any treatment failure, relapse, or death.

  5. Step 5

    Follow-up

    After completing the treatment, follow-up visits will be scheduled to monitor your long-term health and any lasting effects of the treatment. These visits are important to ensure your continued well-being and to gather data for the study.

Who can join the trial?

13 criteria

  • The patient must have a type of blood cancer called Acute Myeloid Leukemia (AML), but not a subtype called APL.
  • The patient must have experienced a return of the disease (1st or 2nd relapse) or the disease has not responded to treatment (refractory).
  • The patient must be suitable for both low intensity therapy and high dose chemotherapy, as determined by their doctor.
  • Both types of treatment (low intensity therapy and high dose chemotherapy) must be available and can be provided according to local medical practices.
  • No specific treatment should be considered better for the patient than the options in the study. This includes:
    • No other drug is proven to be better than the study options.
    • No medical reasons to avoid one of the study options.
    • The patient does not prefer to avoid one of the study options.
    • The patient has enough social support to undergo either treatment option.
    • The patient must be a male or female aged over 18 years.
    • The patient must have an ECOG performance status of less than 4, which is a scale used to assess how a disease affects a patient's daily living abilities.
    • If the patient is a woman, she must not be pregnant or breastfeeding. Women who can have children must have a negative pregnancy test within 14 days before starting treatment and must use highly effective birth control methods during the study and for 6 months after the last treatment.
    • If the patient is a man, he and his female partner who can have children must use two methods of birth control during the study and for 6 months after the last treatment.
    • The patient must be willing and able to provide informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

  • Patients who do not have acute myeloid leukemia cannot participate. Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range includes both adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • Low Intensity Therapy

    is a treatment approach that uses medications or therapies that are less aggressive and have fewer side effects compared to high intensity treatments. This type of therapy is often used for patients who may not tolerate strong treatments well, such as those with other health issues or older adults. The goal is to control the disease while maintaining a better quality of life.

  • High Intensity Therapy

    involves the use of stronger medications or therapies that aim to aggressively target and eliminate cancer cells. This approach is typically used for patients who are able to withstand more intensive treatment. The aim is to achieve a more significant reduction in cancer cells, but it may come with more side effects.

What is already known about the treatment

Low Intensity Therapy – This medication is administered in a form that is less aggressive than traditional high-intensity treatments, typically involving oral or intravenous methods. It is currently being studied in clinical trials for its effectiveness in treating patients with acute myeloid leukemia (AML) who have relapsed or are refractory to other treatments. The main therapeutic indication is to improve event-free survival in these patients. At the molecular level, low intensity therapy works by targeting specific pathways in cancer cells to slow their growth and spread. It is classified pharmacologically as a less aggressive form of chemotherapy, aiming to balance efficacy with reduced side effects.

Investigated diseases

Acute myeloid leukemia – Acute myeloid leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. The disease progresses quickly and can lead to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding. As the abnormal cells multiply, they can spread to other parts of the body, including the liver, spleen, and lymph nodes. The progression of the disease can vary, but it typically involves a rapid decline in health due to the accumulation of these abnormal cells. The condition requires medical attention to manage its progression and impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514517-35-00Protocol codeIRST204.07Estimated enrolment267 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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