Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma
NCT ID: NCT00693602
Last Updated: 2017-04-26
Study Results
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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COMPLETED
PHASE1
87 participants
INTERVENTIONAL
2006-06-30
2011-12-31
Brief Summary
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Detailed Description
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To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase.
TREATMENT PLAN
Erwinia L-asparaginase administration will be given according to the protocol or non-protocol treatment plan under which the patient is currently being treated.
Erwinase will be discontinued in any patient experiencing an allergic reaction or any Grade 3 or higher adverse event believed to be attributable to this agent.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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1
Erwinase
Chemotherapy
Interventions
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Erwinase
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Informed consent explained to and signed by parent/legal guardian, with emphasis that although approved for use in Europe and Canada, Erwinase is NOT approved by the United States Food and Drug Administration
Exclusion Criteria
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Parexel
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Sima Jeha, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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ERWASE
Identifier Type: -
Identifier Source: org_study_id
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