A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Tumor Lysis Syndrome
Both
Tumor Lysis Syndrome
Trial Information
A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the uricolytic response to rasburicase treatment
Outcome Time Frame:
5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
Safety Issue:
No
Principal Investigator
Sharon Chang
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Taiwan: Department of Health
Study ID:
L_8637
NCT ID:
NCT00651911
Start Date:
July 2003
Completion Date:
July 2004
Related Keywords:
- Tumor Lysis Syndrome
- Tumor Lysis Syndrome
Name | Location |
|---|---|
| Sanofi-Aventis | Bridgewater, New Jersey 08807 |
