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Study on Methotrexate and Dexamethasone for Infants Under One Year with Acute Lymphoblastic Leukemia

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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 treating infants under one year old who have been diagnosed with a specific type of blood cancer called acute lymphoblastic leukemia (ALL) or a similar condition known as mixed phenotype acute leukemia (MPAL). The study aims to improve the outcomes for these young patients by using a treatment protocol called Interfant-21. This protocol includes a combination of medications that are commonly used in cancer treatment. These medications include methotrexate, dexamethasone, tioguanine, daunorubicin, vincristine sulfate, mitoxantrone, asparaginase, cyclophosphamide monohydrate, etoposide, mercaptopurine, prednisone, and blinatumomab. Some of these medications are given as injections, while others are taken orally as tablets or suspensions.

The purpose of the study is to see if this new treatment approach can help improve the chances of survival without the cancer coming back. The study will follow the infants through different phases of treatment, which may include receiving some of these medications in a hospital setting. The treatment plan is designed to be as effective as possible while minimizing side effects. The study will also compare the results to previous treatment protocols to see if there is an improvement in outcomes.

Throughout the study, the infants will be closely monitored by healthcare professionals to ensure their safety and to track their progress. The study will collect information on how well the treatment works, any side effects experienced, and the overall health of the infants. This information will help doctors understand more about how to treat this type of leukemia in very young children and may lead to better treatment options 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

    Initial assessment

    Upon joining the clinical trial, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure the patient meets the criteria for participation.

  2. Step 2

    Induction therapy

    The first phase of treatment is called induction therapy. During this phase, several medications are administered to reduce the number of cancer cells. These medications include methotrexate (injection and tablet form), dexamethasone (tablet), daunorubicin (injection), vincristine sulfate (injection), and asparaginase (injection).

    The specific dosage and frequency of these medications are determined by the medical team based on individual patient needs. This phase aims to achieve remission, where no cancer cells are detectable.

  3. Step 3

    Consolidation therapy

    Following induction therapy, consolidation therapy is administered to eliminate any remaining cancer cells. Medications used in this phase include mitoxantrone (infusion), etoposide (infusion), cyclophosphamide (injection), and cytarabine (injection).

    This phase is crucial for preventing the cancer from returning and typically lasts several weeks.

  4. Step 4

    Maintenance therapy

    The final phase is maintenance therapy, which helps to keep the cancer in remission. This involves taking medications such as mercaptopurine (oral suspension), methotrexate (tablet), and prednisone (tablet) over a longer period.

    The goal is to maintain remission and monitor for any signs of cancer returning. Regular follow-up appointments are scheduled to assess progress and adjust treatment as necessary.

  5. Step 5

    Follow-up and monitoring

    Throughout the trial, regular follow-up appointments are necessary to monitor health and response to treatment. These appointments may include physical exams, blood tests, and other assessments.

    The medical team will provide guidance on managing any side effects and ensure the treatment plan is effective.

Who can join the trial?

4 criteria

  • Patients must have a new diagnosis of B-precursor acute lymphoblastic leukemia (ALL) or B-cell mixed phenotype acute leukemia (MPAL). These are specific types of blood cancer.
  • The leukemia must have a specific genetic change called KMT2A-rearrangement.
  • Patients must be 365 days old or younger at the time of diagnosis.
  • Parents or legal guardians must provide written informed consent. This means they agree to let their child participate in the study after being fully informed about it.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of leukemia other than acute lymphoblastic leukemia cannot participate. Acute lymphoblastic leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who have not been newly diagnosed with KMT2A-rearranged (KMT2A-r) infant acute lymphoblastic leukemia are excluded. This is a specific genetic change found in some leukemia cases.
  • Patients who are not infants are excluded. Infants are typically children under one year of age.
  • Patients who are not part of the vulnerable population selected for this study cannot participate. Vulnerable populations may include groups like infants or those with specific health conditions.
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Investigated drugs

  • Prednisone

    is a medication that helps reduce inflammation and suppresses the immune system. In this trial, it is used to help control the leukemia by reducing the number of cancer cells in the body.

  • Vincristine

    is a type of chemotherapy drug that works by stopping the growth of cancer cells. It is used in this trial to help kill the leukemia cells and prevent them from spreading.

  • Daunorubicin

    is another chemotherapy drug that targets and kills cancer cells. It is used in this trial to help reduce the number of leukemia cells in the body.

  • Cytarabine

    is a chemotherapy medication that interferes with the DNA of cancer cells, preventing them from growing and multiplying. It is used in this trial to help eliminate leukemia cells.

  • Asparaginase

    is a medication that breaks down a nutrient called asparagine, which leukemia cells need to survive. By reducing the availability of asparagine, this drug helps to kill the leukemia cells.

  • 6-Mercaptopurine

    is a chemotherapy drug that interferes with the growth of cancer cells. It is used in this trial to help control the leukemia by reducing the number of cancer cells.

What is already known about the treatment

Medication Name – This medication is administered orally or intravenously, depending on the specific treatment protocol. It is currently being studied in clinical trials for its effectiveness in treating acute lymphoblastic leukemia (ALL) in infants. The main therapeutic indication is for infants under one year with a specific genetic rearrangement known as KMT2A-rearranged ALL. At the molecular level, the medication works by targeting and disrupting the cancer cells' ability to grow and divide. It is classified pharmacologically as an antineoplastic agent, which means it is used to stop the growth of cancer cells.

Investigated diseases

Acute lymphoblastic leukemia – Acute lymphoblastic leukemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. It begins in the bone marrow, where blood cells are produced, and can quickly spread to the blood and other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. The disease progresses rapidly, leading to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding due to the lack of normal blood cells. As the number of lymphoblasts increases, they crowd out normal cells, impairing the body's ability to fight infections and carry oxygen. The progression of the disease can vary, but it typically requires prompt medical attention to manage the rapid growth of abnormal cells.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-502503-30-00Protocol codeSP-MH20INTEstimated enrolment264 patientsSponsorPrincess Maxima Center For Pediatric Oncology

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).