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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Lymphoma; Leukemia

Treatments: Drug: Rasburicase (SR29142)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631579

ARD5290

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)