Erwinase Master Treatment Protocol

NCT ID: NCT00590915

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Leukemia, Acute Lymphoblastic Acute Lymphoid Leukemia

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Erwinase

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher Bioservices

INDUSTRY

Sponsor Role collaborator

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Phoenix Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Related Links

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http://www.phoenixchildrens.com

Phoenix Children's Hospital

http://www.eusapharma.com

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

Other Identifiers

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IND-290

Identifier Type: -

Identifier Source: secondary_id

Erwinase

Identifier Type: -

Identifier Source: org_study_id

NCT01009164

Identifier Type: -

Identifier Source: nct_alias

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