Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184041
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2005-09-12
Brief Title:
Intensified Post Remission Therapy Containing PEG-Asparaginase
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase
Status:
COMPLETED
Status Verified Date:
2014-05
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:
This study is for patients with recently diagnosed blood cancer called acute lymphoblastic leukemia ALL The standard treatment for this disease consists of many chemotherapy drugs that are given in different combinations in several steps Each step of treatment is called a cycle Patients will be treated with the chemotherapy drugs that are routinely used in ALL and which are given in multiple treatment cycles over several months All the chemotherapy drugs that are used in this study have been approved by the Food and Drug Administration FDA
One of the drugs which is typically given to patients with ALL is called Asparaginase It is given together with the other drugs throughout the different cycles of treatment This drug can be derived from several sources The standard source is called E coli Asparaginase which is associated with a risk of allergic reactions This drug stays in the body for a very short period of time therefore it has to be injected daily for 9-14 days in a cycle of treatment
In this study a different form of Asparaginase will be used called PEG-Asparaginase also called Oncospar which remains in the body for about two weeks therefore it can be given only once in a cycle of treatment and still maintains high blood levels of the drug PEG-Asparaginase has recently been approved by the FDA to treat ALL Most of the experience with the drug has been in children with ALL In children it was found to be as safe as the standard form of Asparaginase and with less allergic reaction It was also found to have the same effectiveness on ALL The experience with this drug in adults has been more limited
The purpose of the study is to find out what side effects occur in adults when PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the response to treatment of ALL Another purpose is to find out if the allergic reactions are reduced with PEG-Asparaginase In children there is some early information that PEG-Asparaginase produces fewer antibodies than Ecoli Asparaginase Therefore another purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop antibodies against the drug
One of the drugs which is typically given to patients with ALL is called Asparaginase It is given together with the other drugs throughout the different cycles of treatment This drug can be derived from several sources The standard source is called E coli Asparaginase which is associated with a risk of allergic reactions This drug stays in the body for a very short period of time therefore it has to be injected daily for 9-14 days in a cycle of treatment
In this study a different form of Asparaginase will be used called PEG-Asparaginase also called Oncospar which remains in the body for about two weeks therefore it can be given only once in a cycle of treatment and still maintains high blood levels of the drug PEG-Asparaginase has recently been approved by the FDA to treat ALL Most of the experience with the drug has been in children with ALL In children it was found to be as safe as the standard form of Asparaginase and with less allergic reaction It was also found to have the same effectiveness on ALL The experience with this drug in adults has been more limited
The purpose of the study is to find out what side effects occur in adults when PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the response to treatment of ALL Another purpose is to find out if the allergic reactions are reduced with PEG-Asparaginase In children there is some early information that PEG-Asparaginase produces fewer antibodies than Ecoli Asparaginase Therefore another purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop antibodies against the drug
Detailed Description:
None
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