Trial | NCT00590915  Report issue

Official Title

Erwinase Master Treatment Protocol

  • Phase

    N/A

  • Study Type

    Expanded Access

  • Status

    No longer available

  • Study Participants

    None
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 Started
Dec 26
2007
Last Update
Apr 12
2012
Estimate

Drug 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.

  • Other names: Erwinase

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
No Results Posted