This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
199
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Erasmus MC
Rotterdam, Netherlands
To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter
Time frame: March 2012
To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
Time frame: March 2012
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