Erwinase Study in Patients With Acute Lymphoblastic Leukemia

Completed · Not applicable

Conditions studied: Leukemia

In brief

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. This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

Key facts

Study ID

NCT00506597

Run by

M.D. Anderson Cancer Center

People needed

33

Starts

2007-05-01

Expected to finish

2012-02-01

Last updated by the study team

2014-09-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: no restrictions
• Patient must give written informed consent to receive Erwinase® under Investigational New Drug (IND) 290.
• Patient must be treated for Acute Lymphoblastic Leukemia
• Patient with either T or B cell lymphoma being treated with Asparaginase.
• 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.
• Patient with previously documented local or systemic reactions to E. coli derived L-Asparaginase.
• Patients who are on Elspar® (including those enrolled in a clinical trial randomized to Elspar®) and where Elspar® is not available.

You may not qualify if…

• Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
• Previous acute pancreatitis
• Pregnant or lactating woman

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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