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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
CHU Grenoble Alpes La Tronche France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hôpital Archet 2 Nice France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital Beaujon Clichy France
Hôpital Pontchaillou-CHU Rennes Rennes France
CHU Caen​ Caen France
CHU Limoges / Hôpital de la Mère et de l’Enfant Limoges France
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Cha Cbzht Rjledzqklhj Lyon France
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Ccnbon Hiumuhmhylb Ruskvswx Ufsrwqabylkos Dp Tvrjg Tours France
Clic Dm Nswcu Vandoeuvre Les Nancy France
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Hcomhrcf Umoutnofgqjhzq Ssszttacnl &pnrwdu Hpqvbnu dm Hvgbowmpjkk STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
19.09.2016

Trial locations

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.

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 ID:
2024-514243-29-01
Protocol code:
P091205
NCT ID:
NCT02716233
Trial Phase:
Therapeutic confirmatory (Phase III)

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