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Study on Bortezomib and Drug Combination for Children with High-Risk Relapsed Acute Lymphoblastic Leukemia (ALL)

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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 Relapsed Acute Lymphoblastic Leukemia (ALL), a type of cancer that affects the blood and bone marrow. The study aims to improve treatment outcomes for children who have experienced a return of this disease after initial treatment. The trial will compare the effectiveness of standard chemotherapy with and without the addition of Bortezomib, a medication that is being tested for its potential to enhance treatment results.

Participants in the study will receive one of two treatment plans. One group will receive standard chemotherapy, while the other group will receive standard chemotherapy combined with Bortezomib. The study will monitor how well each treatment plan works in achieving a second complete remission, which means the cancer is no longer detectable in the body. The trial will also look at other important outcomes, such as the length of time patients remain free from cancer and overall survival rates.

The medications used in this study include Methotrexate, Dexamethasone, Mitoxantrone, Pegaspargase, Vincristine Sulfate, and Bortezomib. These drugs are administered through injections or infusions, which means they are given directly into the bloodstream. The study will take place over several years, with regular assessments to track the progress and health of the participants. The goal is to find the most effective treatment plan for children with high-risk relapsed ALL, potentially improving 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

    The study is designed for children under 18 years with a confirmed diagnosis of relapsed acute lymphoblastic leukemia (ALL).

    Participation requires written informed consent and enrollment at a participating center.

  2. Step 2

    Induction phase

    The goal is to improve the rate of achieving a second complete remission (CR2).

    Participants are randomly assigned to one of two groups: one receiving standard chemotherapy and the other receiving standard chemotherapy plus bortezomib.

  3. Step 3

    Medication administration

    Medications include methotrexate, dexamethasone, mitoxantrone, pegaspargase, vincristine sulfate, and bortezomib.

    These are administered through intravenous infusion or injection, depending on the specific medication.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    The effectiveness of the treatment is evaluated through various tests, including cytology.

  5. Step 5

    Consolidation phase

    This phase aims to maintain remission and further reduce leukemia cells.

    The treatment plan may be adjusted based on the response during the induction phase.

  6. Step 6

    Follow-up

    Long-term follow-up is conducted to monitor overall survival and event-free survival rates.

    The study is expected to continue until August 2028, with ongoing assessments of treatment outcomes.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of first relapsed precursor B-cell or T-cell **Acute Lymphoblastic Leukemia (ALL)**. This means the leukemia has returned after initial treatment.
  • Must be a child under 18 years old at the time of joining the study.
  • Must meet **High Risk (HR)** criteria, which includes any T-cell bone marrow relapse, early or very early isolated bone marrow relapse, or very early isolated or combined extramedullary relapse. This refers to specific conditions of the leukemia returning.
  • Must be enrolled in a participating center, meaning the study is being conducted at a location where the patient can participate.
  • Must have written informed consent, which means agreeing to participate in the study after understanding all the details and risks.
  • The start of treatment must be within the study period, meaning the treatment should begin while the study is ongoing.
  • Must not be participating in other clinical trials 30 days before joining this study, unless those trials are for primary ALL. This ensures that other treatments do not interfere with the study.

Who cannot join the trial?

4 criteria

  • Patients who have not experienced a return of their Acute Lymphoblastic Leukemia (ALL) after treatment.
  • Patients who are not considered high-risk (HR) for relapsed ALL.
  • Patients who are younger than 2 years old.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Bortezomib is a medication used in this clinical trial to treat high-risk childhood relapsed acute lymphoblastic leukemia (ALL). It is being studied to see if it can improve the rates of complete remission after the initial treatment phase. Bortezomib works by interfering with the growth of cancer cells, which may help to stop or slow down the progression of the disease.

What is already known about the treatment

Bortezomib – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed acute lymphoblastic leukemia (ALL) in children. Bortezomib is already used in medicine for other conditions, but its role in ALL is still under investigation. It works by inhibiting proteasomes, which are structures inside cells that break down proteins, leading to cancer cell death. Bortezomib is classified as a proteasome inhibitor and is being evaluated for its potential to improve remission rates in high-risk relapsed ALL patients.

Investigated diseases

Relapsed Acute Lymphoblastic Leukemia (ALL) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. In relapsed cases, the disease returns after a period of remission. The progression involves the rapid multiplication of these abnormal cells, which can crowd out normal cells, leading to symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. The condition is more common in children but can also occur in adults. Relapsed ALL requires different treatment strategies compared to initial diagnosis due to its resistance to standard therapies.
Trial detailsLast updated 4 Oct 2026
Age0-17PhasePhase IITrial ID2024-513070-21-00Protocol codeIntReALL HR 2010Estimated enrolment233 patientsSponsorCharite Universitaetsmedizin Berlin KöR

sourced from the EU Clinical Trials Register and site verification

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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).