Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents
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.
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