Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140595
Status:
COMPLETED
Last Update Posted:
2011-03-04
First Post:
2005-08-31
Brief Title:
ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients Aged From 18 to 59 Years With Diffuse Large B-cell Lymphoma and a Age-adjusted IPI of 1
Status:
COMPLETED
Status Verified Date:
2011-03
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 study is a multicentric randomized trial evaluating the efficacy of the combination ACVBPrituximab compared to the combination of CHOPrituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index IPI
Detailed Description:
This phase III multicentric open label randomized study is based on the results of previous LNH 93-5 and LNH98-5 studies
The LNH93-5 study has shown that the ACVBP regimen gave a longer EFS 39 vs 29 at 5 years p0005 and a longer overall survival 46 vs 38 at 5 years p0036 than CHOP in patients aged between 61 and 69 with an IPI score 1 However ACVBP had a more important toxicity and a higher treatment related mortality 13 vs 7 p001 specially after 65 years In younger patients ACVBP is better tolerated
The addition of Rituximab to standard CHOP R-CHOP has been shown in LNH98-5 study to improve complete remission rate CR event-free survival EFS and overall survival OS in elderly patients with B-DLCL Considering only patients with an aa-IPI score of 1 the 2 year EFS was 75 in the R-CHOP group as compared with 42 in the CHOP group
This study is designed to test whether addition of rituximab to ACVBP is better than R-CHOP in patients younger than 60 Primary endpoint is event-free survival we expect a gain in 2 years-EFS of 10 in R-ACVBP group as compared with R-CHOP group
This study is a multicentric phase III open-label randomized trial evaluating the efficacy of ACVBPrituximab compared to CHOPrituximab in patients aged from 18 to 59 years with non previously treated diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index
The LNH93-5 study has shown that the ACVBP regimen gave a longer EFS 39 vs 29 at 5 years p0005 and a longer overall survival 46 vs 38 at 5 years p0036 than CHOP in patients aged between 61 and 69 with an IPI score 1 However ACVBP had a more important toxicity and a higher treatment related mortality 13 vs 7 p001 specially after 65 years In younger patients ACVBP is better tolerated
The addition of Rituximab to standard CHOP R-CHOP has been shown in LNH98-5 study to improve complete remission rate CR event-free survival EFS and overall survival OS in elderly patients with B-DLCL Considering only patients with an aa-IPI score of 1 the 2 year EFS was 75 in the R-CHOP group as compared with 42 in the CHOP group
This study is designed to test whether addition of rituximab to ACVBP is better than R-CHOP in patients younger than 60 Primary endpoint is event-free survival we expect a gain in 2 years-EFS of 10 in R-ACVBP group as compared with R-CHOP group
This study is a multicentric phase III open-label randomized trial evaluating the efficacy of ACVBPrituximab compared to CHOPrituximab in patients aged from 18 to 59 years with non previously treated diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index
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