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

Sponsor

St. Jude Children's Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00693602

Collaborator

Jazz Pharmaceuticals (Industry), Parexel (Industry)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia Non Hodgkins Lymphoma	Drug: Erwinase	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Erwinase Chemotherapy

Arm

Intervention/Treatment

Experimental: 1

Drug: Erwinase

Chemotherapy

Outcome Measures

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 [June 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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