Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Patient suffering from:
- acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric
acid level ; or
- lymphoma,Stage ≥ III without regard to uric acid level; or
- lymphomas, Stage II with bulky disease; or
- lymphoma or leukemia, without regard to classification or morphology, with uric acid
level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
Japan: Ministry of Health, Labor and Welfare