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Erwinase Master Treatment Protocol

Information source: Phoenix Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
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: No longer available

Sponsored by: Phoenix Children's Hospital

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

Additional Information

Phoenix Children's Hospital

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

Fisher BioServices - U.S. distributor for Erwinase


Last updated: April 11, 2012

Page last updated: August 23, 2015

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