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
  Purpose

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.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Non Hodgkins Lymphoma
Drug: Erwinase
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Erwinase
Chemotherapy

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693602

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
EUSA Pharma (US), Inc.
Parexel
Investigators
Principal Investigator: Sima Jeha, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00693602     History of Changes
Other Study ID Numbers: ERWASE
Study First Received: June 4, 2008
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014