Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome
- <18 years of age
- Patient with newly diagnosed hematological malignancies presenting with
- 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
- 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
- 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.
- 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.