Informations générales (source: ClinicalTrials.gov)
A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents (CAALL-F01)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
avril 2016
avril 2026
29 juin 2024
A still major question in the field of acute lymphoblastic leukemia (ALL) in children -
an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the
adolescents - is the optimal use of L-asparaginase (ASNase). It is known that
administering ASNase results in the depletion of asparagine circulating in the blood,
which starves the leukemic cells and results in their death. But indeed the use of ASNase
varies between protocols considering the different brands, the dose and the
administration modalities. Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was
thus developed with the goal of reducing the immunogenicity of the native ASNase.
This is a French prospective multicentric cohort study of children and adolescents with
ALL, stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk
(stratified in 3 groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell
ALL).
It aims to answer to two different issues:
1. Randomized question: what is the best way to administer pegaspargase? A cohort of
children and adolescents with standard or medium risk ALL will be randomized to
receive during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two
infusions of ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive
2500 IU/m2 or 1250 IU/m2 per dose during consolidation and delayed intensification
according to the initial arm of randomization.
2. Non randomized question: In the High/Very High Risk groups, a non randomized
intensification of the scheme of asparaginase administration is proposed during
induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered.
All patients will receive 2500 IU/m2 per dose during consolidation and delayed
intensifications.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | BARUCHEL Andre | 18/04/2025 07:56:20 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | BARUCHEL Andre | 18/04/2025 07:56:20 | Contacter | ||
| AP-HP - Hôpital Robert Debré | BARUCHEL Andre | 18/04/2025 07:56:20 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU - 25030 - Besançon - France | Pauline Simon, MD | Contact (sur clinicalTrials) | |||
| CHU - 06200 - Nice - France | Pierre-Simon Rohrlich, MD | Contact (sur clinicalTrials) | |||
| CHU - 29609 - Brest - France | Liana Carausu, MD | Contact (sur clinicalTrials) | |||
| CHU - 31059 - Toulouse - France | Geneviève Plat, MD | Contact (sur clinicalTrials) | |||
| CHU - 35203 - Rennes - France | Virginie Gandemer, MD | Contact (sur clinicalTrials) | |||
| CHu - 37044 - Tours - France | Pascale Blouin, MD | Contact (sur clinicalTrials) | |||
| CHU - 38043 - Grenoble - France | Dominique Plantaz, MD | Contact (sur clinicalTrials) | |||
| CHU - 42270 - Saint Etienne - France | Sandrine Thouvenin-Doulet, MD | Contact (sur clinicalTrials) | |||
| CHU - 44093 - Nantes - France | Caroline Thomas, MD | Contact (sur clinicalTrials) | |||
| CHU - 49033 - Angers - France | Isabelle Pellier, MD | Contact (sur clinicalTrials) | |||
| CHU - 59037 - Lille - France | Françoise Mazingue, MD | Contact (sur clinicalTrials) | |||
| CHU - 63003 - Clermont-Ferrand - France | Justyna Kanold, MD | Contact (sur clinicalTrials) | |||
| CHU - 76031 - Rouen - France | Pascale Schneider, MD | Contact (sur clinicalTrials) | |||
| CHU - 86000 - Poitiers - France | Frédéric Millot, MD | Contact (sur clinicalTrials) | |||
| CHU - 87042 - Limoges - France | Caroline Oudot, MD | Contact (sur clinicalTrials) | |||
| Chu-Ihope - 69373 - Lyon - France | Yves Bertrand, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU - 13385 - Marseille - France | Gérard Michel, MD | Contact (sur clinicalTrials) | |||
| CHU - 14033 - Caen - France | Odile Minckes, MD | Contact (sur clinicalTrials) | |||
| CHU - 21079 - Dijon - France | Elodie Colomb, MD | Contact (sur clinicalTrials) | |||
| CHU - 33076 - Bordeaux - France | Yves Perel, MD | Contact (sur clinicalTrials) | |||
| CHU - 34295 - Montpellier - France | Nicolas Sirvent, MD | Contact (sur clinicalTrials) | |||
| CHU - 51100 - Reims - France | Stéphanie Gordes-Grosjean, MD | Contact (sur clinicalTrials) | |||
| CHU - 54511 - Nancy - France | Claudine Schmitt, MD | Contact (sur clinicalTrials) | |||
| CHU - 67098 - Strasbourg - France | Patrick Lutz, MD | Contact (sur clinicalTrials) | |||
| CHU - 80054 - Amiens - France | Catherine Devoldere, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- ALL L1 or L2
- B-lineage or T- lineage ALL
- ALL L1 or L2
- B-lineage or T- lineage ALL
- L3 (Burkitt's leukemia)
- Mixed Phenotype Acute Leukemia (WHO criteria).
- Infant ALL (age ≤ 365 days)
- Philadelphia (Ph)+/Breakpoint Cluster region (BCR)-Abelson (ABL) ALL