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Elitek (Rasburicase) Immuno-Monitoring Study

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor Lysis Syndrome

Phase: N/A

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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.

Clinical Details

Official title: A Multicenter Registry Study of Anti-rasburicase Antibodies in Patients Retreated With Rasburicase (SR29142) in the Context of Relapsing Leukemia/Lymphoma Who Experienced Subsequent Hypersensitivity Reaction(s) or Loss of Uricolytic Activity: An Immuno-Monitoring Observational Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population.

Titer/type of anti-rasburicase antibodies in eligible population.

Eligibility

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Previous history of rasburicase exposure and history of administration of a repeat (2nd) series of rasburicase injections (in the context of supportive care for relapsing leukemia/lymphoma) and subsequent development of either a hypersensitivity reaction (HSR) or loss of uricolytic activity (defined as failure to achieve uric acid level of < or = 7. 5 mg/dl measured 48 hours after the first rasburicase injection). 1. A severe hypersensitivity reaction (NCI Grade 3, 4 or 5) is defined as: Allergic reaction; allergy; anaphylactic shock; bronchospasm; bullous skin

eruption; dermatitis - exfoliative; drug hypersensitivity; dyspnea; hypotension;

hypoxia; rash; rash - erythematous; rash - maculopapular, urticaria;

pyrexia/fever; edema; chest discomfort; hypersensitivity (NOS); pharynx discomfort; hoarseness; pharyngeal erythema; pruritus; erythema; localized

exfoliation; rash - papular; swelling ¿ face/facial; toxic skin eruption; hot

flush; flushing; rash - macular; rash - pruritic; pruritus - allergic.

2. Loss of uricolytic activity can be defined as:

- uric acid levels > 7. 5 mg/dl measured 48 hours after the first rasburicase

injection¿, which is a time point coincident with administration of the third dose of rasburicase (within that second course of treatment with this agent). 2. Patients should have received at least 2 doses of rasburicase during the repeat (2nd) administration in the event of loss or uricolytic activity. At least 1 dose of rasburicase should be administered during the repeat (2nd) administration for diagnosis of HSR. Exclusion criteria: 1. Concomitant treatment with human IV immunoglobulin (IVIG) 2. Concomitant treatment with TNF-alpha antagonists/inhibitors, i. e. adalimumab, infliximab, and etanercept 3. Concomitant treatment with Interferon-alpha (IFN-alpha) 4. Unwillingness or inability to comply with the requirements of the protocol. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Investigational Site Number 3, Valhalla, New York 10595, United States

Investigational Site Number 4, Oklahoma City, Oklahoma 73104, United States

Investigational Site Number 2, Memphis, Tennessee 38105, United States

Investigational Site Number 1, Houston, Texas 77030, United States

Additional Information

Starting date: February 2010
Last updated: January 30, 2013

Page last updated: August 20, 2015

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