NCT00693602

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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

• Acute Lymphoblastic Leukemia
• Non Hodgkins Lymphoma

Interventions

Type	Name	Description
DRUG	Erwinase	Chemotherapy

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-06-09
• Last updated: 2017-04-26

Locations

1 site across 1 country: United States