Erwinase Study in Patients With Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

1. Age: no restrictions

2. Patient must give written informed consent to receive Erwinase® under Investigational New Drug (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