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Study on Pegaspargase for Treating Acute Lymphoblastic Leukemia in Children and Adolescents

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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 acute lymphoblastic leukemia (ALL), a type of cancer that affects the blood and bone marrow, in children and adolescents. The treatment being tested in this study is called pegaspargase, which is a medication used to treat ALL. Pegaspargase is given as an injection and works by breaking down a substance in the body that cancer cells need to grow.

The purpose of the study is to evaluate how effective and safe different schedules of pegaspargase are for patients aged 12 months to less than 18 years who have been newly diagnosed with standard or medium-risk ALL. The study will also look at the effects of a more intense treatment schedule for those with high or very high-risk ALL. Participants will receive pegaspargase as part of their treatment plan, and the study will monitor how well the medication works and any side effects that may occur.

Throughout the study, researchers will assess the activity of pegaspargase in the body and monitor for any severe side effects, such as issues with the pancreas or allergic reactions. The study will also explore the occurrence of rare subtypes of ALL and their impact on treatment outcomes. The trial aims to provide valuable information on the best ways to use pegaspargase in treating ALL in young patients.

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 trial

    Upon joining the trial, consent is required. This involves signing a document that confirms understanding of the trial and agreement to participate.

    Eligibility is confirmed for children and adolescents aged over 12 months but under 18 years, diagnosed with acute lymphoblastic leukemia (ALL).

  2. Step 2

    Induction phase

    The induction phase begins with the administration of the medication pegaspargase through an injection. This phase aims to reduce leukemia cells in the body.

    The medication schedule is divided into different schemes based on risk groups. The goal is to assess the effectiveness and tolerance of these schedules.

  3. Step 3

    Monitoring and assessment

    Regular monitoring occurs to evaluate the activity of the medication and any side effects. This includes checking for adequate asparaginase activity by day 33 of the induction phase.

    Monitoring also involves observing for any severe side effects such as central nervous system thrombosis, pancreatitis, allergic reactions, and liver issues between days 12 and 49.

  4. Step 4

    Consolidation phase

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

    The specific details of this phase depend on the response to the induction treatment and the risk group classification.

  5. Step 5

    Follow-up and evaluation

    Long-term follow-up is conducted to assess the overall effectiveness of the treatment and monitor for any late side effects.

    The trial aims to evaluate the five-year event-free survival, disease-free survival, and overall survival rates for participants.

Who can join the trial?

3 criteria

  • Children and adolescents aged more than 12 months but less than 18 years.
  • Diagnosed with either B-lineage or T-lineage ALL (types of blood cancer).
  • Written informed consent must be obtained before the 8th day of treatment.

Who cannot join the trial?

8 criteria

  • Patients who are not newly diagnosed with standard or medium-risk ALL (Acute Lymphoblastic Leukemia).
  • Patients who are younger than 12 months or older than 18 years.
  • Patients who have a different type of leukemia or cancer.
  • Patients who have a severe allergy to the medication used in the study.
  • Patients who have a serious infection that is not controlled.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

Acute Lymphoblastic Leukemia Treatment Protocol: This clinical trial is focused on treating children and adolescents with acute lymphoblastic leukemia (ALL). The study aims to evaluate different treatment schemes to find the most effective and least toxic approach. The trial involves a fractionated scheme and an intensified scheme, which are different ways of administering the treatment over a set period. The goal is to determine which method works better in terms of how the body processes the medication and how well patients tolerate the treatment.

What is already known about the treatment

Pegaspargase – Pegaspargase is administered as an injection, typically given into a muscle or vein. It is currently being studied in clinical trials for its effectiveness and safety in treating children and adolescents with acute lymphoblastic leukemia (ALL), a type of cancer affecting white blood cells. The main therapeutic use of Pegaspargase is to help treat ALL by breaking down a substance called asparagine, which cancer cells need to grow. At the molecular level, Pegaspargase works by depleting asparagine, thereby starving the cancer cells. It is classified as an antineoplastic agent, which means it is used to stop the growth of cancer cells.

Investigated diseases

Acute Lymphoblastic Leukemia (ALL) – 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 ALL can vary, with some cases advancing more quickly than others, depending on factors like the specific genetic mutations involved.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-514243-29-01Protocol codeP091205Estimated enrolment1 636 patientsSponsorAssistance Publique Hopitaux De Paris

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