Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-01 @ 8:42 PM
Study NCT ID:
NCT01097369
Status:
TERMINATED
Last Update Posted:
2013-01-31
First Post:
2010-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elitek (Rasburicase) Immuno-Monitoring Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015275', 'term': 'Tumor Lysis Syndrome'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'business decision due to low subject recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-03-31', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence/frequency of presence of anti-rasburicase antibodies in eligible population.', 'timeFrame': 'Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity'}, {'measure': 'Titer/type of anti-rasburicase antibodies in eligible population.', 'timeFrame': 'Day 1, i.e. within 48 hours of identification /diagnosis of HSR (hypersensitivity reaction) or loss of uricolytic activity'}]}, 'conditionsModule': {'conditions': ['Tumor Lysis Syndrome']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. 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).\n\n 1. A severe hypersensitivity reaction (NCI Grade 3, 4 or 5) is defined as:\n\n 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.\n 2. Loss of uricolytic activity can be defined as:\n\n * 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).\n2. 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.\n\nExclusion criteria:\n\n1. Concomitant treatment with human IV immunoglobulin (IVIG)\n2. Concomitant treatment with TNF-alpha antagonists/inhibitors, i.e. adalimumab, infliximab, and etanercept\n3. Concomitant treatment with Interferon-alpha (IFN-alpha)\n4. Unwillingness or inability to comply with the requirements of the protocol.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01097369', 'briefTitle': 'Elitek (Rasburicase) Immuno-Monitoring Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RASBU_L_02990'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anti-rasburicase antibodies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 3', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 4', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 2', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 1', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}