Elitek (Rasburicase) Immuno-Monitoring Study

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01097369

Enrollment

Registered

2010-04-01

Start date

2010-02-28

Completion date

2010-02-28

Last updated

2013-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor Lysis Syndrome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results