Elitek (Rasburicase) Immuno-Monitoring Study

Terminated

• Conditions: Tumor Lysis Syndrome

• Registration Number: NCT01097369
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To determine the incidence, titer and type of anti-rasburicase antibodies in the context of hypersensitivity reaction(s) or the loss of uricolytic activity occurring in patients with relapsed leukemia/lymphoma who have been re-treated with rasburicase and have experienced a hypersensitivity reaction or loss of uricolytic activity.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population.	Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity
Titer/type of anti-rasburicase antibodies in eligible population.	Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity

Trial Locations

Locations (4)

Investigational Site Number 2; 🇺🇸 Memphis, Tennessee, United States

Investigational Site Number 4; 🇺🇸 Oklahoma City, Oklahoma, United States

Investigational Site Number 1; 🇺🇸 Houston, Texas, United States

Investigational Site Number 3; 🇺🇸 Valhalla, New York, United States