Know Cancer

forgot password

Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia

Not Enrolling

Thank you

Trial Information

Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia

The Study Drug:

Erwinia L-Asparaginase helps stop the growth of cancer cells by blocking the nutrients that
cancer cells needed to survive.

Study Visits:

Erwinia L-Asparaginase will be given either outpatient or inpatient, depending upon your

If you are allergic to E. Coli Asparaginase or Pegylated Asparaginase, you will be given 6
doses every other day.

You will receive Erwinia L-Asparaginase as an injection through a needle in your vein, under
the skin, or in your muscle, as directed by your study doctor.

You will be monitored closely by your nurse and your doctor before, during, and after
receiving the drug for any side effects. If you develop a severe allergy to Erwinia
L-Asparaginase, you may not receive any more asparaginase therapy.

The length of study will be based upon on the ALL treatment you are currently receiving.
Your doctor will discuss the details of your treatment schedule with you.

This is an investigational study. Erwinia L-Asparaginase is not FDA approved. The FDA
allows patients with acute lymphoblastic leukemia who have an allergic reaction to the
U.S.-approved L-asparaginases to receive Erwinia L-Asparaginase. Up to 35 patients will take
part in this study. All will be enrolled at M. D. Anderson.

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Toxicity Data

Outcome Time Frame:

3 Years

Safety Issue:


Principal Investigator

Robert J. Wells, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

February 2012

Related Keywords:

  • Leukemia
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Erwinia L-Asparaginase
  • Erwinase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



UT MD Anderson Cancer Center Houston, Texas  77030