Erwinase Study in Patients With Acute Lymphoblastic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00506597|
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Erwinase||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
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.
Other Name: Erwinia L-Asparaginase
- Participant Toxicity Data [ Time Frame: 3 Years ]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 [ Time Frame: 4 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506597
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J. Wells, MD||M.D. Anderson Cancer Center|