NCT00590915

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
Last Updated

January 23, 2026

Status Verified

April 1, 2012

First QC Date

December 26, 2007

Last Update Submit

January 22, 2026

Conditions

Leukemia, Acute LymphoblasticAcute Lymphoid Leukemia

Keywords

ALL

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.

Also known as: Erwinase

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous allergic reaction to Erwinia L-asparaginase (Erwinase)
  • Previous acute pancreatitis
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

asparaginase erwinia chrysanthemi recombinantAsparaginase

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Last Updated

January 23, 2026

Record last verified: 2012-04