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

Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631579
• Other study ID #: ARD5290
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2008
• Last updated: October 1, 2009
• Start date: April 2003
• Est. completion date: June 2004

Study information

• Verified date: October 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia
• Leukemia
• Lymphoma

Intervention

Drug:
• Rasburicase (SR29142)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
Secondary	Pharmacokinetic parameters and anti-SR29142 antibodies