Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erwinase
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Acute Lymphoblastic Leukemia, Leukemia, Erwinia L-Asparaginase, Erwinase
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
- Previous acute pancreatitis
- Pregnant or lactating woman
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erwinase
Arm Description
6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
Outcomes
Primary Outcome Measures
Participant Toxicity Data
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
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
Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.
Secondary Outcome Measures
Full Information
NCT ID
NCT00506597
First Posted
July 20, 2007
Last Updated
September 4, 2014
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00506597
Brief Title
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Official Title
Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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 condition.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Acute Lymphoblastic Leukemia, Leukemia, Erwinia L-Asparaginase, Erwinase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erwinase
Arm Type
Experimental
Arm Description
6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
Intervention Type
Drug
Intervention Name(s)
Erwinase
Other Intervention Name(s)
Erwinia L-Asparaginase
Intervention Description
If allergic to E.Coli Asparaginase = 1 Dose (20,000 Units/m^2) Daily; If allergic to Pegylated Asparaginase = 6 Doses (25,000 Units/m^2) Daily Every Other Day. Received as an injection through a needle in vein, under the skin, or in muscle.
Primary Outcome Measure Information:
Title
Participant Toxicity Data
Description
Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.
Time Frame
3 Years
Title
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
Description
Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.
Time Frame
4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Previous allergic reaction to Erwinia L-Asparaginase (Erwinase ®)
Previous acute pancreatitis
Pregnant or lactating woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Wells, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
The University of Texas MD Anderson Cancer Center Official Website
Learn more about this trial
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
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