Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162656
Status:
COMPLETED
Last Update Posted:
2012-03-28
First Post:
2005-09-07
Brief Title:
Treatment of Mature B-cell LymphomaLeukaemia
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Treatment of Mature B-cell LymphomaLeukaemia A SFOP LMB 96CCG 5961UKCCSG NHL 9600 Cooperative Study
Status:
COMPLETED
Status Verified Date:
2012-03
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 is an international trial conducted by three cooperative groups SFOP France Belgium Netherlands CCG USA Canada Australia and UKCCSG UK and Ireland Children with mature B-cell lymphomaleukaemia are stratified into three different risk groups A B C and receive treatment of progressive intensity Randomized trials in the 2 biggest groups B and C test whether reduced therapy is equivalent to standard intensive therapy LMB-89 B and C in terms of event free survival The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity impaired fertility and secondary malignancy In group B the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 andor the elimination of COPADM3 In group C the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment
Detailed Description:
Group B Randomized trial with factorial design The 4 treatment arms are standard LMB89 therapy B reduction of cyclophosphamide CPM in COPADM2 deletion of COPADM3 both reduction and deletion Randomization occurs following COPADM1 and is stratified for national group histology large cell small non cleaved cell and stage Murphy I orII Murphy IIILDH2N Murphy IIILDH2N or Murphy IV
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C Randomized trial The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE deletion of the last 3 maintenance courses Randomization occurs following COPADM2 and is stratified for national group histology large cell small non cleaved cell and CNS disease
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C
The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS
Group C Randomized trial The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE deletion of the last 3 maintenance courses Randomization occurs following COPADM2 and is stratified for national group histology large cell small non cleaved cell and CNS disease
The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C
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