Erwinase Master Treatment Protocol

N/ANo Longer AvailableNCT00590915

Phoenix Children's Hospital

Overview

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

Conditions

Leukemia, Acute Lymphoblastic Acute Lymphoid Leukemia

Interventions

Erwinia L-asparaginaseDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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