Fasturtec TLS Treatment / Prophylysis

March 31, 2008 updated by: Sanofi

A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the uricolytic response to rasburicase treatment
Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome
Time Frame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Sharon Chang, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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