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.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Toxicity Data
Robert J. Wells, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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