Erwinase Master Treatment Protocol (EMTP)
January 22, 2026 updated by: Phoenix Children's Hospital
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 Overview
Status
No longer available
Intervention / Treatment
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
First Posted (Estimated)
January 11, 2008
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 22, 2026
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Hemic and Lymphatic Diseases
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Hydrolases
- Enzymes
- Enzymes and Coenzymes
- Amidohydrolases
- Asparaginase
- asparaginase erwinia chrysanthemi recombinant
Other Study ID Numbers
- Erwinase
- IND-290
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.