French study aims to perfect leukemia treatment for kids
NCT ID NCT02716233
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
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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
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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
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU
Besançon, 25030, France
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CHU
Amiens, 80054, France
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CHU
Angers, 49033, France
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CHU
Bordeaux, 33076, France
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CHU
Brest, 29609, France
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CHU
Caen, 14033, France
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CHU
Clermont-Ferrand, 63003, France
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CHU
Dijon, 21079, France
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CHU
Grenoble, 38043, France
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CHU
Lille, 59037, France
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CHU
Limoges, 87042, France
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CHU
Marseille, 13385, France
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CHU
Montpellier, 34295, France
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CHU
Nancy, 54511, France
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CHU
Nantes, 44093, France
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CHU
Nice, 06200, France
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CHU
Poitiers, 86000, France
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CHU
Reims, 51100, France
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CHU
Rennes, 35203, France
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CHU
Rouen, 76031, France
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CHU
Saint-Etienne, 42270, France
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CHU
Strasbourg, 67098, France
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CHU
Toulouse, 31059, France
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CHU
Tours, 37044, France
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CHU Armand Trousseau
Paris, 75012, France
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CHU Robert Debré
Paris, 75019, France
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CHU Saint Louis
Paris, 75010, France
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Chu-Ihope
Lyon, 69373, France
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