Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

Completed · Phase 1

Conditions studied: Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma

In brief

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.

Key facts

Study ID

NCT00693602

Run by

St. Jude Children's Research Hospital

People needed

87

Starts

2006-06-01

Expected to finish

2011-12-01

Last updated by the study team

2017-04-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Documented history of severe hypersensitivity or intolerance to Erwinase

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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