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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborators: Jazz Pharmaceuticals; Parexel
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

• 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 Criteria:

• Documented history of severe hypersensitivity or intolerance to Erwinase