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

Sanofi50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperuricemia Leukemia Lymphoma

Interventions

Rasburicase (SR29142)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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 (1)

Sanofi-Aventis

Tokyo, Japan

Outcomes

Primary Outcomes

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

Secondary Outcomes

Pharmacokinetic parameters and anti-SR29142 antibodies

Data from ClinicalTrials.gov

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