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Study on Improving Treatment for Children and Adolescents with Acute Lymphoblastic Leukemia Using Bortezomib, Blinatumomab, 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 lymphoblastic leukemia in children and adolescents. The study aims to explore the effectiveness of different treatment strategies to improve outcomes for patients with this type of cancer. The trial involves several medications, including Oncaspar (pegaspargase), BLINCYTO (blinatumomab), Erwinase (crisantaspase), and other chemotherapy drugs such as prednisolone, etoposide, bortezomib, methotrexate, cyclophosphamide, vincristine, ifosfamide, cytarabine, doxorubicin, fludarabine, mercaptopurine, and tioguanine. Some patients will receive a placebo as part of the study.

The purpose of the study is to determine if adding certain medications or changing the treatment schedule can improve the chances of staying cancer-free for longer periods. The study will compare different groups of patients who receive various combinations of these treatments. For example, one group will receive additional therapy with the drug bortezomib during a phase called consolidation, while another group will receive blinatumomab as part of their treatment plan. The study will also look at whether extending the treatment phase and increasing doses of certain drugs like cyclophosphamide, cytarabine, and 6-mercaptopurine can improve outcomes.

Participants in the study will follow a treatment plan that includes receiving medications through injections or infusions, and some drugs may be taken orally. The study will monitor the participants over time to see how well the treatments work and to check for any side effects. The goal is to find the best treatment approach for children and adolescents with acute lymphoblastic leukemia to improve their chances of recovery and long-term health.

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

    Joining the study

    Upon joining the study, the patient will be assessed to confirm eligibility based on the diagnosis of acute lymphoblastic leukemia or related conditions.

    The patient must be under 18 years of age and have provided written consent for participation.

  2. Step 2

    Induction phase

    The induction phase involves initial treatment to reduce leukemia cells. Medications such as prednisolone (oral) and vincristine (intravenous) are administered.

    The goal is to achieve remission, where no leukemia cells are detectable.

  3. Step 3

    Consolidation phase

    During the consolidation phase, treatment aims to eliminate any remaining leukemia cells. This phase may include medications like methotrexate (intravenous) and cytarabine (intravenous).

    The duration and specific medications depend on the patient's response to the induction phase.

  4. Step 4

    Randomization and additional therapy

    Patients are randomized to receive additional therapy based on their risk category. High-risk patients may receive blinatumomab (intravenous infusion) for 28 days per cycle.

    Intermediate-risk patients may receive one cycle of blinatumomab as post-reintensification therapy.

  5. Step 5

    Maintenance phase

    The maintenance phase involves lower-intensity treatment to prevent relapse. Medications such as mercaptopurine (oral) and methotrexate (oral) are used.

    This phase continues for an extended period, often lasting several months to years.

  6. Step 6

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and detect any signs of relapse.

    The frequency of visits and tests will be determined by the healthcare team based on the patient's progress.

Who can join the trial?

7 criteria

  • The patient must have been newly diagnosed with **acute lymphoblastic leukemia**. From 1st September 2023 onwards, only those with a **T-cell phenotype** are eligible.
  • The patient may have been newly diagnosed with **mixed phenotype acute leukemia (MPAL)**, which means the leukemia shows characteristics of more than one type of blood cell. It must meet one of the following criteria:
    • **Biphenotypic** with a dominant T or B lineage assignment. From 1st September 2023 onwards, only those with a dominant T lineage assignment are eligible.
    • **Bilineal** with a dominant lymphoblastic population. From 1st September 2023 onwards, only T lymphoblastic populations are eligible, or if there is another reasonable reason to treat the patient with an ALL-based therapy regimen.
    • The patient may have been newly diagnosed with **acute undifferentiated leukemia**, which means the leukemia cells do not show specific characteristics of any type of blood cell.
    • The patient must be under 18 years old (up to 17 years and 365 days) at the time of diagnosis.
    • The patient must be enrolled in a participating center, which means the hospital or clinic is part of the study.
    • There must be written informed consent for the patient to participate in the trial and for their data to be transferred and processed. This means that the patient or their guardian agrees to the study and understands what it involves.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of leukemia than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain treatments that are not allowed in the study.
  • Patients who have allergies or reactions to the study medications.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • Bortezomib

    is a medication used in this trial to see if it can improve outcomes for children and adolescents with early high-risk acute lymphoblastic leukemia. It is added during an extended phase of treatment to see if it helps in better managing the disease compared to the standard treatment.

  • Blinatumomab

    is an immunotherapy drug used in the trial for patients with high-risk or intermediate-risk acute lymphoblastic leukemia. It is given in cycles to see if it can improve the chances of staying disease-free. The trial is testing if adding this medication after initial treatments can lead to better outcomes.

  • Methotrexate

    is used in this trial as part of a treatment plan for high-risk patients. It is administered directly into the spinal fluid to help prevent or treat leukemia in the central nervous system. The trial is examining if this approach, combined with other treatments, can improve patient outcomes.

  • Cyclophosphamide

    , Cytarabine, and 6-Mercaptopurine are chemotherapy drugs used in the trial for patients with early non-standard risk T-cell acute lymphoblastic leukemia. The trial is testing if increasing the doses of these medications during the consolidation phase of treatment can improve the chances of staying disease-free.

What is already known about the treatment

  • Bortezomib

    Bortezomib is administered intravenously and is currently being studied in clinical trials for its potential to improve outcomes in children and adolescents with acute lymphoblastic leukemia. It is primarily used for its ability to inhibit proteasomes, which are structures within cells that break down proteins. By blocking these proteasomes, Bortezomib disrupts the degradation of proteins that regulate cell cycle and apoptosis, leading to cancer cell death. It is classified as a proteasome inhibitor and is being evaluated for its effectiveness in enhancing treatment during the consolidation phase of leukemia therapy.

  • Blinatumomab

    Blinatumomab is given as a continuous intravenous infusion and is under investigation for its role in treating high-risk acute lymphoblastic leukemia in children and adolescents. It is a type of immunotherapy that works by engaging the body's immune system to target and destroy leukemia cells. Blinatumomab is a bispecific T-cell engager that connects T-cells to cancer cells, facilitating the immune attack on the cancer. It is classified as a monoclonal antibody and is being tested for its potential to improve survival rates when used in post-consolidation therapy.

  • Methotrexate

    Methotrexate is administered intrathecally, meaning it is injected directly into the spinal fluid, and is being studied for its effectiveness in combination with other therapies for acute lymphoblastic leukemia. It is used to prevent cancer cells from growing by interfering with their DNA synthesis. Methotrexate is classified as an antimetabolite and is being evaluated for its role in enhancing the effects of immunotherapy in post-consolidation treatment phases.

  • Cyclophosphamide

    Cyclophosphamide is given intravenously and is being explored for its potential to improve treatment outcomes in acute lymphoblastic leukemia by increasing the intensity of the consolidation phase. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Cyclophosphamide is classified as an alkylating agent and is being tested for its ability to enhance the effectiveness of standard chemotherapy regimens.

  • Cytarabine

    Cytarabine is administered intravenously and is being studied for its role in intensifying the consolidation phase of treatment for acute lymphoblastic leukemia. It acts by interfering with DNA synthesis, thereby inhibiting the growth of cancer cells. Cytarabine is classified as an antimetabolite and is being evaluated for its potential to improve survival rates when used in combination with other chemotherapy drugs.

  • 6-Mercaptopurine

    6-Mercaptopurine is taken orally and is being investigated for its effectiveness in increasing the cumulative dose during the consolidation phase of acute lymphoblastic leukemia treatment. It works by interfering with the synthesis of nucleic acids, which are essential for DNA replication and cell division. 6-Mercaptopurine is classified as an antimetabolite and is being tested for its ability to enhance the overall treatment regimen for leukemia.

Investigated diseases

Acute Lymphoblastic Leukemia in Children and Adolescents – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. It progresses rapidly, leading to a decrease in the number of healthy blood cells, which can cause symptoms such as fatigue, fever, and increased risk of infections. The disease is classified into different risk categories based on genetic factors and response to initial treatment. In some cases, the disease may not respond well to standard treatments, requiring additional therapeutic strategies. The progression of the disease can vary, with some patients experiencing relapses or resistance to treatment. The focus of research is often on improving treatment outcomes and understanding the disease's behavior in different risk groups.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-509856-32-00Protocol codeAIEOP-BFM_ALL_2017Estimated enrolment5 100 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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