Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Phase 2
18 Years
74 Years
18 Years
74 Years
Not Enrolling
Both
Hyperuricemia, Leukemia, Lymphoma
Both
Hyperuricemia, Leukemia, Lymphoma
Trial Information
Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Inclusion Criteria:
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
normal (ULN).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
Principal Investigator
K.K.
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
ARD5290
NCT ID:
NCT00631579
Start Date:
April 2003
Completion Date:
June 2004
Related Keywords:
- Hyperuricemia
- Leukemia
- Lymphoma
- Leukemia
- Lymphoma
- Hyperuricemia
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