Dettagli per singolo studio

DEC-NET Serial number FR368

Published online	11/03/2005 10.32.00
Last updated	19/09/2005 15.39.40

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	LYMPHOID LEUKEMIA ACUTE
Experimental drug
L-Asparaginase Treatment regimen (dosage and duration) -Induction phase: 9 intramuscular administrations of 6000 UI/m2 between days 10 and 26. -Intensification phase (n°1): 6 intramuscular administrations of 6000 UI/m2 between days 3 and 15. -Intensification phase (n°2): 9 intramuscular administrations of 20000 UI/m² betwen days 1 and 30.
Gender	Both
Age (range)	> 1 year and < 10 years
Eligibility criteria
Inclusion criteria
Children with B lineage de novo acute lymphoblastic leukemia (L3 excluded)
Exclusion criteria
Chidren : - with ALL of Burkitt type (standard FAB L3) - who could not be followed - whose parents do not sign the informed consent.
Trial design/methodology
Phase	4
Kind of study	Pharmacokinetics
Design	Etude pilote descriptive, non randomisée (sauf pour les échantillons de sang collectés
Purpose of study
Principal objective: - To determine the percentage of patients having an altered enzymatic activity of E coli-asparaginase(<100 UI/L) and a high antibody level to detect the children known as "silent responders". Secondary objective: - To elaborate a population pharmacokinetic/pharmacodynamic model using the primary pharmacokinetic parameters of E coli-asparaginase previously selected, predicting the evolution of the amino-acid depletion according to the variations of enzyme activity and antibody levels.




Summary of study design, objectives, and ongoing research findings
Descriptive pilot, trial in 30 children included in the protocol Fralle 2000. The individual monitoring asparaginase activity coupled with the measurement of L-asparagine and glutamine levels, the search and titration of antibodies during induction and first intensification will allow to determine the percentage of children "silent responders".