Fasturtec TLS Treatment / Prophylysis
A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
1 other identifier
interventional
45
1 country
1
Brief Summary
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2003
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedApril 3, 2008
March 1, 2008
March 28, 2008
March 31, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis
Bridgewater, New Jersey, 08807, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sharon Chang
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 3, 2008
Study Start
July 1, 2003
Study Completion
July 1, 2004
Last Updated
April 3, 2008
Record last verified: 2008-03