Back to resultsErwinase Master Treatment Protocol (EMTP)
Primary Purpose
Leukemia, Acute Lymphoblastic, Acute Lymphoid Leukemia
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Erwinia L-asparaginase
Sponsored by
About this trial
This is an expanded access trial for Leukemia, Acute Lymphoblastic focused on measuring ALL
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00590915
First Posted
December 26, 2007
Last Updated
April 11, 2012
Sponsor
Phoenix Children's Hospital
Collaborators
Fisher Bioservices, Jazz Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00590915
Brief Title
Erwinase Master Treatment Protocol
Acronym
EMTP
Official Title
Erwinase Master Treatment Protocol
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Phoenix Children's Hospital
Collaborators
Fisher Bioservices, Jazz Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Acute Lymphoblastic, Acute Lymphoid Leukemia
Keywords
ALL
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Erwinia L-asparaginase
Other Intervention Name(s)
Erwinase
Intervention Description
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.
10. Eligibility
Sex
All
Eligibility 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
12. IPD Sharing Statement
Links:
URL
http://www.phoenixchildrens.com
Description
Phoenix Children's Hospital
URL
http://www.eusapharma.com
Description
EUSA Pharma (US), Inc.- manufacturer of Erwinase
Learn more about this trial
Erwinase Master Treatment Protocol
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