Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperuricemia; Leukemia; Lymphoma
Intervention: Rasburicase (SR29142) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
K.K., Study Director, Affiliation: Sanofi-Aventis
Summary
The primary objectives of the study are to evaluate the safety and the efficacy in patients
with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days
in two dosage groups.
Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to
assess anti-SR29142 antibody production in patients with malignant lymphoma and acute
leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the
results of efficacy and safety evaluations.
Clinical Details
Official title: Open-Label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety via physical examination, laboratory tests and adverse events.
Efficacy via plasma uric acid levels.
Secondary outcome: Pharmacokinetic parameters and anti-SR29142 antibodies
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Sanofi-Aventis, Tokyo, Japan
Additional Information
Starting date: April 2003
Last updated: March 6, 2008
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