Fasturtec TLS Treatment / Prophylysis

Phase 4CompletedNCT00651911

Sanofi45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumor Lysis Syndrome

Interventions

urate oxidaseDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Outcomes

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)

Data from ClinicalTrials.gov

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