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Study Summary
No. 2007-0183:.......Leukemia; Lymphoma; Pediatrics......Robert J. Wells......Pediatrics
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Study Summary Title
Study Summary
Number:		2007-0183
Study Title:Erwinia L-asparaginase for Injection IND 290
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Physician New Patient Referral
Name:Robert J. WellsPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1499
Contact us about clinical trials
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General Information
Disease Group:Leukemia
Lymphoma
Pediatrics		Supported By:EUSA Pharma, Inc.
Phase of Study:N/AReturn
Visit:		Based on the ALL treatment protocol that the patient is enrolled.
Treatment
Agents:		Erwinia AsparaginaseHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Based on the ALL treatment protocol that the patient is enrolled.
Description/
Intervention:		The goal of this clinical research study is to allow doctors to use Erwinia
L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to
E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the
treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma.
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Study Objectives / Outcomes
PRIMARY:
1. To enable US patients who are treated for Acute Lymphoblastic Leukemia (ALL) and who are allergic to Escherichia Coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia chrysanthemi derived L-Asparaginase (Erwinase®), under IND 290.
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Study Status Information
Study Activation / Registration Date:05/07/2007
IRB Review and Approval Date:05/07/2007
Study Type:Other
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Age: no restrictions

2) Patient must give written informed consent to receive Erwinase® under IND 290.

3) Patient must be treated for Acute Lymphoblastic Leukemia

4) Patient with either T or B cell lymphoma being treated with Asparaginase.

5) Patient must have either systemic hypersensitivity reactions to native (Elspar®) or pegylated (Oncaspar®) E. coli L-Asparaginase. This includes patients with generalized rash with or without anaphylactic symptoms, but not those with only local pain or redness at the site of injection.

6) Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.

7) Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.
Exclusion Criteria:1) Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)

2) Previous acute pancreatitis

3) Pregnant or lactating woman
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Links
Registration Number: NCT00506597
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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