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NCT00693602 Clinical Trial

Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00693602
Other study ID # ERWASE
Secondary ID
Status Completed
Phase Phase 1
First received June 4, 2008
Last updated April 24, 2017
Start date June 2006
Est. completion date December 2011

Study information
Verified date December 2011
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or PEG-L-asparaginase.

Description:

Primary Objective

To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase.

TREATMENT PLAN

Erwinia L-asparaginase administration will be given according to the protocol or non-protocol treatment plan under which the patient is currently being treated.

Erwinase will be discontinued in any patient experiencing an allergic reaction or any Grade 3 or higher adverse event believed to be attributable to this agent.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma receiving ALL-type therapy who have developed hypersensitivity or intolerance to E. coli L-asparaginase or PEG-L-asparaginase or both.

- Informed consent explained to and signed by parent/legal guardian, with emphasis that although approved for use in Europe and Canada, Erwinase is NOT approved by the United States Food and Drug Administration

Exclusion Criteria:

- Documented history of severe hypersensitivity or intolerance to Erwinase

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Erwinase
Chemotherapy

Locations
Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (3)
Lead Sponsor Collaborator
St. Jude Children's Research Hospital Jazz Pharmaceuticals, Parexel

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase June 2009
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