Rasburicase (Fasturtec) Registration Trial - Full Text View

Purpose

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 ).

Condition	Intervention	Phase
Hyperuricemia	Drug: Rasburicase Drug: Allopurinol	Phase III

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for:

Allopurinol Allopurinol sodium Rasburicase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Multicenter, Open-Label, Comparison of Rasburicase (Fasturtec) Versus Allopurinol for the Prophylaxis and Treatment of Hyperuricemia in Chinese Patients With Leukaemia or Lymphoma

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Mean plasma uric acid AUC0-96 [ Time Frame: 0hour, 4hour, 12 hour and q12h thereafter ] [ Designated as safety issue: No ]
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing) [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
Biochemistry, hematology, vital signs, physical examination, and adverse events [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
Proportion of patients developing hypertension requiring therapy [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
Assays for circulating antibodies [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage reduction of plasma uric acid concentrations at T4h [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]
Mean plasma uric acid concentrations [ Time Frame: At various timepoints ] [ Designated as safety issue: No ]
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL [ Time Frame: From administration of drug up to end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	October 2007
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IV infusion at a dose level of 0.20mg/kg per day	Drug: Rasburicase 0.20mg/kg per day IV
2: Active Comparator 100mg tablets, administered orally, according to standard medical practice	Drug: Allopurinol 100mg tablets

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607152

Contacts


Contact: Public Registry GMA		publicregistryGMA@sanofi-aventis.com

Locations


China
	Sanofi-Aventis	Recruiting
	Shanghai, China

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Jing Fu	Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	RASBU_L_00351
First Received:	January 22, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00607152
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Leukemia

Allopurinol

Hyperuricemia

Rasburicase

Lymphoma

Additional relevant MeSH terms:

Antimetabolites

Antioxidants

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Free Radical Scavengers

Enzyme Inhibitors

Antirheumatic Agents

Protective Agents

Gout Suppressants

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00607152