Elitek (Rasburicase) Immuno-Monitoring Study
This study has been terminated.
(business decision due to low subject recruitment)
Information provided by (Responsible Party):
First received: March 31, 2010
Last updated: January 30, 2013
Last verified: January 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population. [ Time Frame: Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity ] [ Designated as safety issue: No ]
- Titer/type of anti-rasburicase antibodies in eligible population. [ Time Frame: Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||2 Years and older (Child, Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients are selected as the clinical manifestations for study inclusion (hypersensitivity reaction or the loss of uricolytic activity) are recognized during clinically-indicated re-challenge with rasburicase.
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).
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.
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).
- 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.
- Concomitant treatment with human IV immunoglobulin (IVIG)
- Concomitant treatment with TNF-alpha antagonists/inhibitors, i.e. adalimumab, infliximab, and etanercept
- Concomitant treatment with Interferon-alpha (IFN-alpha)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01097369
|Investigational Site Number 3
|Valhalla, New York, United States, 10595 |
|Investigational Site Number 4
|Oklahoma City, Oklahoma, United States, 73104 |
|Investigational Site Number 2
|Memphis, Tennessee, United States, 38105 |
|Investigational Site Number 1
|Houston, Texas, United States, 77030 |
||Clinical Sciences & Operations
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 31, 2010
||January 30, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Tumor Lysis Syndrome
Immune System Diseases
Physiological Effects of Drugs