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Erwinase Master Treatment Protocol

Erwinase Master Treatment Protocol

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00590915
Acronym
EMTP
Enrollment
Unknown
Registered
2008-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Acute Lymphoblastic, Acute Lymphoid Leukemia

Keywords

ALL

Brief 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.

Interventions

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.

Sponsors

Phoenix Children's Hospital
Lead SponsorOTHER
Fisher Bioservices
CollaboratorINDUSTRY
Jazz Pharmaceuticals
CollaboratorINDUSTRY

Eligibility

Sex/Gender
ALL

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026