Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
10 participants
INTERVENTIONAL
2007-10-31
2009-01-31
Brief Summary
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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 ).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
IV infusion at a dose level of 0.20mg/kg per day
Rasburicase
0.20mg/kg per day IV
2
100mg tablets, administered orally, according to standard medical practice
Allopurinol
100mg tablets
Interventions
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Rasburicase
0.20mg/kg per day IV
Allopurinol
100mg tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Fu
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Shanghai, , China
Countries
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Other Identifiers
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RASBU_L_00351
Identifier Type: -
Identifier Source: org_study_id
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