Acute Lymphoblastic Leukemia Clinical Trial
Official title:
PEG-asparaginase During Two Treatment Courses in the Treatment of Childhood Acute Lymphoblastic Leukemia
The purpose of this study is
1. to determine the correct dose for intramuscular administration
2. to compare the frequency of antibody formation after intramuscular administration of
native E.coli asparaginase and PEG-asparaginase during two treatment courses in the
treatment of childhood lymphoblastic leukemia
Asparaginase is used in the treatment of childhood lymphoblastic leukemia. Approximately 1/3
of the patients develops blocking antibodies against native E.coli asparaginase during the
second exposure, so that they do not benefit from treatment and thus may have a worse
prognosis.
PEG-asparaginase is less immunogenic so that fewer patients may develop antibodies during
the second exposure.
There is no published study about the antibody formation after treatment of children with
PEG-asparaginase during two treatment courses.
The first part of the study is a description of the pharmacokinetics of PEG-asparaginase
after intramuscular administration in order to determine the correct dose.
The second part of the study is a comparison of antibody formation during two treatment
courses after intramuscular administration og native E.coli asparaginase and
PEG-asparaginase.
Other side effects than antibodies will be registered during treatment with
PEG-asparaginase. Finally comparison of the 5-year EFS between the groups (native E.coli
asparaginase and PEG-asparaginase as well as patients who have and have not developed
antibodies) will be evaluated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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