Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222612
Status:
UNKNOWN
Last Update Posted:
2010-02-03
First Post:
2005-09-13
Brief Title:
Medical Research Council MRC Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia ALL Trial UKALL 2003
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Medical Research Council Working Party on Leukaemia in Children UK National Acute Lymphoblastic Leukaemia ALL Trial UKALL 2003
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
RECRUITING
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:
A randomised trial for children with acute lymphoblastic leukemia using the detection of minimal residual disease to define risk groups aiming to answer the questions
1 Can treatment be reduced without compromising efficacy in a MRD-defined low risk group
2 Does further post-remission intensification improve outcome for a MRD-defined high risk group
3 Measure the Quality of Life impact of the different treatment arms on the children and their families
1 Can treatment be reduced without compromising efficacy in a MRD-defined low risk group
2 Does further post-remission intensification improve outcome for a MRD-defined high risk group
3 Measure the Quality of Life impact of the different treatment arms on the children and their families
Detailed Description:
Randomisations
Patients will be assigned to MRD risk groups based on day 29 and post consolidation MRD results and randomised as follows
1 MRD Low Risk Group MRD negative at day 29 and week 11 or positive 1 x 10-4 at day 28 and negative at week 11 will continue on previously assigned Regimens A or B but randomised between two delayed intensifications and one delayed intensification
2 MRD High Risk Group MRD positive 1 x 10-4 at day 29 randomised between previously assigned Regimen A or B and Regimen C
3 MRD Indeterminate Group No MRD result or MRD positive 1 x 10-4 at day 29 and at week 11 will continue on previously assigned Regimen A or B and received two delayed intensifications
Patients will be assigned to MRD risk groups based on day 29 and post consolidation MRD results and randomised as follows
1 MRD Low Risk Group MRD negative at day 29 and week 11 or positive 1 x 10-4 at day 28 and negative at week 11 will continue on previously assigned Regimens A or B but randomised between two delayed intensifications and one delayed intensification
2 MRD High Risk Group MRD positive 1 x 10-4 at day 29 randomised between previously assigned Regimen A or B and Regimen C
3 MRD Indeterminate Group No MRD result or MRD positive 1 x 10-4 at day 29 and at week 11 will continue on previously assigned Regimen A or B and received two delayed intensifications
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