Status:
COMPLETED
Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Jazz Pharmaceuticals
Parexel
Conditions:
Acute Lymphoblastic Leukemia
Non Hodgkins Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or PEG-L-asparaginase.
Detailed Description
Primary Objective 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...
Eligibility Criteria
Inclusion
- Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma receiving ALL-type therapy who have developed hypersensitivity or intolerance to E. coli L-asparaginase or PEG-L-asparaginase or both.
- 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
- Documented history of severe hypersensitivity or intolerance to Erwinase
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00693602
Start Date
June 1 2006
End Date
December 1 2011
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105