Rasburicase (Fasturtec) Registration Trial

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Hyperuricemia

Treatments: Drug: Rasburicase; Drug: Allopurinol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00607152

RASBU_L_00351

Details and patient eligibility

About

Primary:

To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.

Secondary:

To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At high risk of malignancy and/or chemotherapy-induced hyperuricemia
• Performance status less than 3 on ECOG scale or more than 30% KPS scale
• Uric acid concentrations ≥ 8.0mg/dL
• Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia

Exclusion criteria

• Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
• Pregnancy or lactation
• Prior treatment with Uricozyme or Rasburicase
• Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
• Treatment with Allopurinol within the seven days preceding study Day 1
• History of significant atopic allergy problems or documented history of asthma
• History of severe reaction to allopurinol
• Known history of glucose-6-phosphate dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

1

Experimental group

Description:

IV infusion at a dose level of 0.20mg/kg per day

Treatment:

Drug: Rasburicase

2

Active Comparator group

Description:

100mg tablets, administered orally, according to standard medical practice

Treatment:

Drug: Allopurinol