Ignite Creation Date:
2024-05-05 @ 9:06 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00819351
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2009-01-08
Brief Title:
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
NOPHO Treatment Protocol for Children 10 - 179 Years of Age and Young Adults180-450 Years With Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion
Status:
COMPLETED
Status Verified Date:
2017-04
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 purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival
Detailed Description:
20 of children with ALL still fails to be cured The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols
The specific and primary objectives of the randomised study is
To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed
The specific and primary objectives of the randomised study is
To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed
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