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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

Page last updated: December 08, 2011

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