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

This study has been completed.
Sponsor:
Collaborators:
EUSA Pharma (US), Inc.
Parexel
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00693602
First received: June 4, 2008
Last updated: January 3, 2012
Last verified: December 2011
History of Changes

June 4, 2008
January 3, 2012
June 2006
December 2011   (final data collection date for primary outcome measure)
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 [ Time Frame: June 2009 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00693602 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma
Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Acute Lymphoblastic Leukemia
  • Non Hodgkins Lymphoma
Drug: Erwinase
Chemotherapy
Experimental: 1
Intervention: Drug: Erwinase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00693602
ERWASE
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
  • EUSA Pharma (US), Inc.
  • Parexel
Principal Investigator: Sima Jeha, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP