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

St. Jude Children's Research Hospital

Status and phase: Completed; Phase 1

Conditions: Acute Lymphoblastic Leukemia; Non Hodgkins Lymphoma

Treatments: Drug: Erwinase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00693602

ERWASE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Volunteers: No 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

Exclusion criteria

• Documented history of severe hypersensitivity or intolerance to Erwinase

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Erwinase