Dettagli per singolo studio

DEC-NET Serial number GB267

Published online	30/06/2004 13.39.00
Last updated	15/11/2005 9.50.13

Other protocol ID number	N0129118577
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	10/2002 30
Major Disease (ICD9 class)	LEUKEMIA NOS W/O REMSION
Experimental drug
L-asparaginase Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	0 -18
Eligibility criteria
Inclusion criteria
Children with acute lymphoblastic leukaemia, receiving therapy with L-asparaginase at RMCH.
Exclusion criteria
informed consent not given
Trial design/methodology
Phase	4
Kind of study
Design	Laboratory Study
Purpose of study
To determine the relationship between L-asparaginase administration and the magnitude and duration of depletion of asparagine and glutamine in the blood, bone marrow and CSF of children with acute lymphoblastic leukaemia.
Primary outcomes
Inter-patient variation of the relationship between L-asparaginase administration and the magnitude and duration of depletion of asparagine and glutamine in the blood, bone marrow and CSF of children with acute lymphoblastic leukaemia.


Summary of study design, objectives, and ongoing research findings
Thirty children with acute lymphoblastic leukaemia will be studied. Prior to, during and following the administration of L-asparaginase during the remission induction, early and delayed intensification modules of therapy for childhood ALL, the plasma, bone marrow and CSF changes in the levels of asparagine, aspartate, glutamine and glutamate will be measured from samples taken alongside clinically-indicated sampling of blood, bone marrow or CSF. The influence of the development of anti-asparaginase antibodies, expected in 35% of cases, on the above biochemical changes will be made. The laboratory studies will be performed in the Dept for Molecular Drug Design, University of Salford.