Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

Phase 2

Completed

• Conditions: Hyperuricemia; Leukemia; Lymphoma

• Registration Number: NCT00631579
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters and anti-SR29142 antibodies

Trial Locations

Locations (1)

Sanofi-Aventis; 🇯🇵 Tokyo, Japan