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Study on Acute Lymphoblastic Leukemia Treatment in Children and Adolescents Using Bortezomib, Blinatumomab, and Methotrexate Combination

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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 lymphoblastic leukemia (ALL) in children and adolescents. ALL is a type of cancer that affects the blood and bone marrow, where blood cells are made. The study aims to explore the effectiveness of different treatment options to improve outcomes for patients with this condition. The trial involves several medications, including Blinatumomab, Bortezomib, Methotrexate, Prednisone, Prednisolone, Prednisolone Sodium Succinate, Ifosfamide, Crisantaspase, Etoposide, Dexamethasone, Cyclophosphamide, Vincristine Sulfate, Mercaptopurine, Daunorubicin Hydrochloride, Fludarabine Phosphate, Tioguanine, and Vindesine Sulfate. Some of these medications are used to kill cancer cells, while others help manage side effects or enhance the effectiveness of the treatment.

The purpose of the study is to determine if adding certain medications, like Bortezomib and Blinatumomab, to the standard treatment can improve the chances of recovery and reduce the risk of severe side effects. The study is designed to compare the outcomes of patients receiving these additional treatments with those receiving the standard treatment alone. Participants will be randomly assigned to different treatment groups to ensure a fair comparison. The study will monitor the patients' responses to the treatments over time, looking at factors such as the reduction of cancer cells and the occurrence of any side effects.

Throughout the study, patients will receive their treatments either through injections or orally, depending on the medication. The trial will last for several years, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments. The ultimate goal is to find the most effective and safest treatment plan for children and adolescents with acute lymphoblastic leukemia, potentially improving survival rates and quality of life for these young patients.

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 reviewing medical history and conducting necessary tests to ensure the diagnosis of acute lymphoblastic leukemia is accurate.

  2. Step 2

    Treatment phase 1: induction

    The first phase of treatment is called induction. During this phase, various medications are administered to reduce the number of leukemia cells. Medications may include vincristine sulfate and prednisone, which are given intravenously or orally as prescribed by the medical team.

  3. Step 3

    Treatment phase 2: consolidation

    Following induction, the consolidation phase aims to eliminate any remaining leukemia cells. This phase may involve medications such as methotrexate and cytarabine, administered intravenously or orally. The specific regimen and duration depend on individual response to treatment.

  4. Step 4

    Randomization and extended consolidation

    Patients with early high-risk leukemia may undergo randomization to receive additional therapy with bortezomib during an extended consolidation phase. This is compared to standard extended consolidation to evaluate effectiveness.

  5. Step 5

    Treatment phase 3: post-consolidation

    In the post-consolidation phase, patients with high-risk leukemia may receive blinatumomab therapy. This involves three cycles of treatment, each lasting 28 days, with a dosage of 15 micrograms per square meter per day. Additionally, methotrexate is administered intrathecally, which means it is injected into the spinal fluid.

  6. Step 6

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess treatment response and manage any side effects. Follow-up visits are scheduled to ensure the patient's well-being and to gather data on the effectiveness of the treatment.

Who can join the trial?

7 criteria

  • Newly diagnosed with acute lymphoblastic leukemia (a type of blood cancer) or
  • Newly diagnosed with acute undifferentiated leukemia (a type of blood cancer that doesn't fit into a specific category) or
  • Newly diagnosed with mixed phenotype acute leukemia (MPAL) (a type of blood cancer with features of more than one type of leukemia) that meets one of the following:
    • Biphenotypic with a dominant T or B cell type
    • Bilineal with a dominant lymphoblastic population or if there is another good reason to treat with an ALL-based therapy
    • Age less than 18 years (up to 17 years and 365 days) at the day of diagnosis
    • Patient must be enrolled in a participating center
    • Written informed consent to participate in the trial and for the transfer and processing of data

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than acute lymphoblastic leukemia.
  • Patients who have not responded well to previous treatments.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the medications used in the study.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • Bortezomib

    is a medication used in this trial to help treat children with a specific type of leukemia called acute lymphoblastic leukemia. It works by blocking a part of the cell called the proteasome, which is involved in breaking down proteins. By doing this, Bortezomib can help stop cancer cells from growing and multiplying. In this study, it is being tested to see if it can improve the treatment outcomes when added to the standard treatment plan for children who are at high risk of their leukemia coming back.

  • Blinatumomab

    is a type of immunotherapy used in this trial. It helps the body's immune system to find and destroy cancer cells. Blinatumomab works by connecting certain immune cells to the cancer cells, which helps the immune system attack the cancer more effectively. In this study, it is being tested to see if it can reduce the risk of serious side effects from treatment while still effectively treating the leukemia in children who are at high risk.

  • Methotrexate

    is a medication that is used in this trial to treat leukemia by being administered directly into the spinal fluid, which is called intrathecal administration. This method helps to prevent or treat cancer cells that might be hiding in the brain or spinal cord. Methotrexate works by interfering with the growth of cancer cells, slowing down or stopping their ability to multiply. In this study, it is used alongside other treatments to help improve the chances of successfully treating the leukemia.

What is already known about the treatment

  • Bortezomib

    Bortezomib is administered as an injection, typically given by a healthcare professional. It is currently used in clinical trials for treating children with acute lymphoblastic leukemia (ALL), particularly those with early high-risk profiles. The medication works by inhibiting proteasomes, which are structures inside cells that break down proteins, thereby disrupting cancer cell growth and survival. Bortezomib is classified as a proteasome inhibitor and is being studied to see if it can improve treatment outcomes when added to standard therapy.

  • Blinatumomab

    Blinatumomab is given as an intravenous infusion, usually in a hospital setting. It is being tested in clinical trials for children with high-risk acute lymphoblastic leukemia (ALL) to see if it can reduce severe side effects while maintaining treatment effectiveness. This medication acts by engaging the body's immune system to target and destroy cancer cells, specifically by connecting T-cells to cancer cells. Blinatumomab is classified as a bispecific T-cell engager (BiTE) and is being evaluated for its potential to improve patient outcomes in combination with other treatments.

  • Methotrexate

    Methotrexate is administered intrathecally, meaning it is injected directly into the spinal fluid. It is used in clinical trials for children with high-risk acute lymphoblastic leukemia (ALL) to help prevent cancer cells from spreading to the brain and spinal cord. Methotrexate works by interfering with the growth of cancer cells, slowing or stopping their proliferation. It is classified as an antimetabolite and is being studied for its effectiveness in reducing treatment-related toxicities when used alongside other therapies.

Investigated diseases

Acute lymphoblastic leukemia – Acute lymphoblastic leukemia (ALL) is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal blood cells, leading to symptoms such as fatigue, easy bruising, and increased risk of infections. The disease progresses rapidly, with the lymphoblasts multiplying quickly and spreading throughout the body. As the disease advances, it can affect other organs, including the liver, spleen, and lymph nodes. The progression of ALL can vary, with some cases responding well to initial treatment phases, while others may show resistance or relapse. The disease is most common in children, but it can also occur in adults.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-517253-27-00Protocol codeAIEOP-BFM 2017POLANDEstimated enrolment874 patientsSponsorMedical University Of Silesia Katowice Poland

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