Rasburicase for Hyperuricemia
Rasburicase for Hyperuricemia
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.
Inclusion Criteria:

 -  <18 years of age

 -  Patient with newly diagnosed hematological malignancies presenting with hyperuricemia:

 -  Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13
 years old

 Or, patient with newly diagnosed hematological malignancies presenting with high tumor
 burden defined:

 -  Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,

 -  Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the
 following:

 -  At least one lymph node or mass >5 cm in diameter

 -  LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification

 -  Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L)
 regardless of uric acid level. etc.

 Exclusion Criteria:

 -  Patients who have received or are scheduled to receive other investigational drugs in
 30 days prior to the start of SR29142 administration or during the trial period.

 -  Low birth weight infant (<2500g) or gestational age <37 weeks

 -  Patients who have received or are scheduled allopurinol within 72 hrs prior to the
 first dose of SR29142 or during the trial period.

 -  Known history of severe allergic reaction and/or severe asthma.

 -  Known history or family history of glucose-6-phosphate dehydrogenase deficiency.

 -  Known history of hemolysis and methemoglobinemia.

 -  Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x
 ULN, Creatinine > 3.0 x ULN

 -  Uncontrollable infections (including viral infections).

 -  Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.