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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651911

Enrollment

Registered

2008-04-03

Start date

2003-07-31

Completion date

2004-07-31

Last updated

2008-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor Lysis Syndrome

Brief summary

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

Interventions

DRUGurate 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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	5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026