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French study aims to perfect leukemia treatment for kids

NCT ID NCT02716233

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This French study looks at 2,044 children and teens with acute lymphoblastic leukemia (ALL) to find the best way to give the drug pegaspargase. Some patients get one large dose, while others get two smaller doses. The goal is to see which schedule works better and causes fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pegaspargase (ONCASPAR)
What this could lead to
If successful, this could establish a safer and more effective dosing schedule for pegaspargase, improving outcomes for children with ALL.
What could go wrong
This is an observational cohort study, not a randomized controlled trial for all groups, so results may be less definitive. The drug can cause serious side effects like pancreatitis and allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,044 people

The number who actually took part.

Start date

Sep 2016

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Children and adolescents Age \> 12 months but \< 18 yearsB-lineage or T- lineage ALL * Written informed consent obtained before day 8 of treatment Non inclusion criteria: * L3 (Burkitt's leukemia) (LMB type protocols) * Mixed Phenotype Acute Leukemia (WHO criteria). * Infant ALL (age ≤ 365 days (Interfant 06 protocol) * Secondary leukemia * Patients previously treated with chemotherapy (steroid exposed patients can be included and stratified according to Section 3.5) Known allergy to pegylated products * Pregnancy. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant must have a negative serum pregnancy before inclusion and a reliable contraception except oral contraceptives. The contraception should be maintained throughout the study and for 3 months after treatment discontinuation. * Known HIV positivity * CNS thrombosis during Prophase Exclusion Criteria: * Ph+/BCR-ABL ALL (ESPhALL protocol) * CNS thrombosis before D12

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHRU

    Besançon, 25030, France

  • CHU

    Amiens, 80054, France

  • CHU

    Angers, 49033, France

  • CHU

    Bordeaux, 33076, France

  • CHU

    Brest, 29609, France

  • CHU

    Caen, 14033, France

  • CHU

    Clermont-Ferrand, 63003, France

  • CHU

    Dijon, 21079, France

  • CHU

    Grenoble, 38043, France

  • CHU

    Lille, 59037, France

  • CHU

    Limoges, 87042, France

  • CHU

    Marseille, 13385, France

  • CHU

    Montpellier, 34295, France

  • CHU

    Nancy, 54511, France

  • CHU

    Nantes, 44093, France

  • CHU

    Nice, 06200, France

  • CHU

    Poitiers, 86000, France

  • CHU

    Reims, 51100, France

  • CHU

    Rennes, 35203, France

  • CHU

    Rouen, 76031, France

  • CHU

    Saint-Etienne, 42270, France

  • CHU

    Strasbourg, 67098, France

  • CHU

    Toulouse, 31059, France

  • CHU

    Tours, 37044, France

  • CHU Armand Trousseau

    Paris, 75012, France

  • CHU Robert Debré

    Paris, 75019, France

  • CHU Saint Louis

    Paris, 75010, France

  • Chu-Ihope

    Lyon, 69373, France

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