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Study on Treating Acute Myeloid Leukemia in Children and Adolescents Using Gemtuzumab Ozogamicin and a Drug Combination

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 treatments for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study involves several medications, including Cytarabine, Mitoxantrone, Fludarabine Phosphate, Etoposide, Prednisolone Sodium Succinate, Daunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Methylprednisolone, Hydrocortisone, Methotrexate, and Dexrazoxane. These medications are used in various forms, such as solutions for injection or infusion, and are administered intravenously, which means they are given directly into a vein.

The purpose of this study is to improve the overall event-free survival for children and adolescents who have been newly diagnosed with AML. The study will explore whether adding Gemtuzumab Ozogamicin to the first course of treatment can enhance early anti-leukemic effects in patients with a specific type of AML known as CD33-positive. Additionally, the study will compare the effectiveness of two versus three courses of consolidation therapy, which is a phase of treatment aimed at maintaining remission, in patients who are considered to be at standard risk.

Participants in the study will receive different combinations of the medications mentioned above, depending on their specific treatment plan. The study will monitor the participants' response to the treatment over time, focusing on their event-free survival, which refers to the length of time they remain free from certain complications or events related to their disease. The study will also assess the safety and side effects of the treatments. The trial is expected to continue until 2036, with recruitment having started in August 2023.

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 study

    Upon joining the study, the patient is confirmed to have newly diagnosed Acute Myeloid Leukemia (AML) and meets the age criteria of 1 day to 18 years.

    Informed consent is obtained from the patient or their guardians, and the patient is assessed for their ability to comply with follow-up and manage any side effects.

  2. Step 2

    Induction phase

    The induction phase involves the administration of several medications to reduce leukemia cells. These include Cytarabine, Mitoxantrone, Fludarabine, Etoposide, and Daunorubicin, all given intravenously.

    The goal is to achieve a significant reduction in leukemia cells, with a focus on achieving minimal residual disease (MRD) levels below 0.1% before starting the second induction course.

  3. Step 3

    Consolidation phase

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

    Medications such as Gemtuzumab ozogamicin and Methylprednisolone are administered intravenously, while Methotrexate is given intrathecally to target the central nervous system.

  4. Step 4

    Randomization

    Patients may be randomized to receive additional treatments based on their response to initial therapies and specific characteristics of their leukemia cells, such as CD33 positivity.

    This step involves comparing different treatment strategies to determine the most effective approach for maintaining remission.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's response to treatment and manage any side effects.

    The primary focus is on event-free survival (EFS) and disease-free survival (DFS), ensuring the patient remains in remission without significant adverse events.

Who can join the trial?

6 criteria

  • The patient must have been newly diagnosed with **Acute Myeloid Leukemia (AML)**. This means the leukemia started on its own and is not due to previous bone marrow problems or treatments.
  • The patient must be between **1 day and 18 years old** at the time of the initial diagnosis.
  • There must be **written informed consent** from the patient and/or their parents or legal guardians if the patient is a minor. This means they agree to participate in the study and understand what it involves.
  • The patient must be able to **attend scheduled follow-up appointments** and manage any side effects from the treatment.
  • For a specific part of the study called **induction randomization**, the patient's leukemia cells must show **CD33 positivity**. This is determined by a test called **flow cytometry**, which measures certain markers on the cells. The patient must also have given consent to participate in this part of the study.
  • For another part of the study called **consolidation randomization**, the patient must be part of the **CHIP-AML22 protocol** and classified in the **Standard Risk Group** according to the study's guidelines. The patient must also have given consent to participate in this part of the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have a diagnosis of Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow.
  • Patients who are not children or adolescents. This study is specifically for younger individuals.
  • Patients who are not CD33-positive. CD33 is a protein found on the surface of certain blood cells, and its presence is important for this study.
  • Patients who are not part of the standard-risk group. This refers to a specific group of patients with a certain level of risk for their condition.
  • Patients who are not eligible for the specific treatment courses being studied. This means they must be able to receive the treatments being tested in the trial.
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Investigated drugs

GO (Gemtuzumab Ozogamicin) is a medication used in the trial to treat children and adolescents with newly diagnosed acute myeloid leukemia (AML). It is specifically used for patients whose cancer cells have a marker called CD33. The trial aims to see if adding GO to the first course of treatment can improve the early effectiveness against leukemia compared to not using GO.

What is already known about the treatment

Gemtuzumab Ozogamicin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Acute Myeloid Leukemia (AML) in children and adolescents. It is an antibody-drug conjugate that targets the CD33 antigen on leukemia cells, delivering a cytotoxic agent directly to these cells to induce cell death. Gemtuzumab Ozogamicin is classified as an antineoplastic agent and is being evaluated for its potential to improve early anti-leukemic efficacy when added to standard induction therapy.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. 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. Symptoms may include fatigue, fever, frequent infections, and easy bruising or bleeding. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. AML is more common in adults but can also occur in children and adolescents. The progression of the disease can vary, with some cases advancing rapidly while others may progress more slowly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504999-25-00Protocol codeMH21CHIEstimated enrolment875 patientsSponsorPrincess Maxima Center For Pediatric Oncology

sourced from the EU Clinical Trials Register and site verification

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