Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00816049
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2008-12-23
Brief Title:
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia ALL - 6MP Consolidation Therapy
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children 10 - 179 Years of Age and Young Adults 18-45 Years of Age With ALL Efficacy of Individualised 6MP Dosing During Consolidation Therapy
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:
ALL2008con
Brief Summary:
The purpose of this study is to increase the fraction of patients who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85
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 increase the fraction of patients who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85 We will additionally measure EFS and toxicity as secondary end points of effect
The specific and primary objectives of the randomised study is
To increase the fraction of patients who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85 We will additionally measure EFS and toxicity as secondary end points of effect
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