Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration. Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sanofi-Aventis
Tokyo, Japan
Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.
Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
G6PD activity will be measured in only patients who demonstrate hemolysis.
Anti-SR29142 antibody and Anti-SCP antibody will be measured.
PK parameters.
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