Elitek (Rasburicase) Immuno-Monitoring Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Tumor Lysis Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anti-rasburicase antibodies

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No