Fasturtec TLS Treatment / Prophylysis

Tumor Lysis Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651911
• Other study ID #: L_8637
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: March 31, 2008
• Start date: July 2003
• Est. completion date: July 2004

Study information

• Verified date: March 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumor Lysis Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the uricolytic response to rasburicase treatment		5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)	No
Secondary	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		5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)	Yes