Erwinase Master Treatment Protocol
Information source: Phoenix Children's Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Acute Lymphoblastic; Acute Lymphoid Leukemia
Intervention: Erwinia L-asparaginase (Drug)
Phase: N/A
Status: Available
Sponsored by: Phoenix Children's Hospital Overall contact:
Paul Plourde, MD, Phone: 215-230-9622, Email: Paul.Plourde@eusapharma.com
Summary
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.
Clinical Details
Official title: Erwinase Master Treatment Protocol
Study design: N/A
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Paul Plourde, MD, Phone: 215-230-9622, Email: Paul.Plourde@eusapharma.com Additional Information
Phoenix Children's Hospital EUSA Pharma (US), Inc.- manufacturer of Erwinase Fisher BioServices - U.S. distributor for Erwinase
Last updated: July 19, 2011
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