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...
Brief Summary
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Phoenix Children's Hospital Other
Overall Clinical Trial Officials and Contacts
Overall Contact: Paul Plourde, MD 215-230-9622 Paul.Plourde@eusapharma.com
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01009164
