Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506597
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2007-07-20
Brief Title:
Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Erwinia L-Asparaginase Erwinase Study in Patients With Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Ecoli L-asparaginase or Pegylated Ecoli 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
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 US-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
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 US-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None