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NCT00590915 Clinical Trial

Erwinase Master Treatment Protocol

Acute Lymphoid Leukemia Clinical Trial

— EMTP  

Official title:
Erwinase Master Treatment Protocol

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00590915
Other study ID # Erwinase
Secondary ID IND-290
Status No longer available
Phase N/A
First received December 26, 2007
Last updated April 11, 2012

Study information
Verified date April 2012
Source Phoenix Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Expanded Access

Clinical Trial 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.

Other known NCT identifiers
  • NCT01009164

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Phoenix Children's Hospital Fisher Bioservices, Jazz Pharmaceuticals
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