Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: Erwinase (Drug)
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Robert J. Wells, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
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.
Official title: Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participant Toxicity Data
Number of Participants Treated With Erwinase as a Replacement for 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
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 at The University of Texas (UT) MD Anderson Cancer Center.
Minimum age: N/A.
Maximum age: N/A.
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
7. Patients who are on Elspar┬« (including those enrolled in a clinical trial randomized
to Elspar┬«) and where Elspar┬« is not available.
1. Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ┬«)
2. Previous acute pancreatitis
3. Pregnant or lactating woman
Locations and Contacts
UT MD Anderson Cancer Center, Houston, Texas 77030, United States
The University of Texas MD Anderson Cancer Center Official Website
Starting date: May 2007
Last updated: September 4, 2014