Fasturtec TLS Treatment / Prophylysis | Clinical Trial

Key information

Conditions

Tumor Lysis Syndrome Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urate oxidase

Drug

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.

Other names: rasburicase

Primary outcomes

To assess the uricolytic response to rasburicase treatment

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

Secondary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2004
First posted: Apr 3, 2008
Registry last updated: Apr 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed