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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
Not Enrolling
Both
Tumor Lysis Syndrome

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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-AventisBridgewater, New Jersey  08807