Official Title: “Erwinase Master Treatment Protocol”

The purpose of this study is to make Erwinase available to patients with acute lymphoblastic leukemia (ALL) who have had previous allergic reactions to certain formulations of L-asparaginase.

Study Type: Expanded Access

Study Design: N/A

Intervention(s) in this Clinical Trial

• Drug: Erwinia L-asparaginase
  • Substitute Erwinia L-asparaginase 25,000 international units per meters squared, IM every other day (including weekends and holidays) x 6 doses for each dose of PEG-asparaginase that is replaced. NOTE: Erwinia L-asparaginase dosing to replace native E.coli L-asparaginase varies; consult protocol for specifics.

Inclusion Criteria:

• Patient must give written informed consent to receive Erwinase.
• Patient must be treated for acute lymphoblastic leukemia.
• Patient must have either systemic hypersensitivity reactions to native (Elspar) or pegylated E.coli asparaginase (Oncaspar). This includes patients with generalized rash with or without anaphylactic symptoms, or patients with previously documented local or systemic reactions to E.coli derived L-asparaginase.

Exclusion Criteria:

• Previous allergic reaction to Erwinia L-asparaginase (Erwinase)
• Previous acute pancreatitis
• Pregnant or lactating woman

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Phoenix Children's Hospital

Overall Clinical Trial Officials and Contacts

Overall Contact: Paul Plourde, MD 215-230-9622 Paul.Plourde@eusapharma.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00590915

Study ID Number: Erwinase

ClinicalTrials.gov Identifier: NCT00590915

Health Authority: United States: Food and Drug Administration

Phoenix Children's Hospital

EUSA Pharma (US), Inc.- manufacturer of Erwinase

Fisher BioServices - U.S. distributor for Erwinase