Fasturtec TLS Treatment / Prophylysis

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-07-31

Brief Summary

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An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome

Detailed Description

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Conditions

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Tumor Lysis Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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urate oxidase

First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.

Intervention Type DRUG

Other Intervention Names

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rasburicase

Eligibility Criteria

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Inclusion Criteria

* Chemotherapy planned for at least 3 cycles
* Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
* With a minimum life expectancy of 3 months
* Uric acid \> 8 mg%
* Negative pregnancy test \< or =to 2 weeks and efficient contraceptive method.
* Negative HIV serology \< or =to 4 weeks
* Patient or legal guardian has signed a written informed consent

Exclusion Criteria

* Hypersensitivity to uricases or any of the excipients
* Known history of G6PD deficiency.
* Previous treatment with Rasburicase or Uricozyme®
* Pregnancy or lactation
* Treatment with any investigational drug within 30 days before planned first Rasburicase administration

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Sharon Chang

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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L_8637

Identifier Type: -

Identifier Source: org_study_id