Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144807
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2005-09-02
Brief Title:
ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma Age-adjusted IPI 2-3
Status:
COMPLETED
Status Verified Date:
2015-09
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 trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma
Detailed Description:
This phase II non randomized study is based on the results of the LNH 98-5 LNH 87-2 LNH 93-3 and LNH 98-3B studies
To date the ACVBP regimen is considered as the reference induction treatment of the GELA in patients with 2-3 adverse prognostic factors Indeed neither NCVBP regimen LNH87-2 nor ECVBP LNH93-3 led to increase the complete remission rate More recently the addition of etoposide to doxorubicin and cyclophosphamide LNH98-3B did not enhanced the complete remission rate with more toxicity In patients 60 years with 2-3 adverse prognostic factors the complete remission rate remained less than 65 in all these studies Consequently increasing the quality of response remains a major goal in this group of young patients with adverse prognostic factors
It has been shown that the addition of rituximab to CHOP regimen significantly improved the CR rate in elderly patients with previously untreated large B-cell lymphoma when compared with CHOP alone without additional toxicities Moreover event-free survival and overall survival were found to be longer in the R-CHOP group The present trial will evaluate the response rate obtained after four cycles of ACVBP combined to rituximab R-ACVBP before high dose therapy consolidative treatment in this group of higher risk patients
The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell support was beneficial to high risk patients in good response after a full induction phase The long-term results of this randomised study prompted us to consider high dose therapy as the best consolidative option for these patients
To date the ACVBP regimen is considered as the reference induction treatment of the GELA in patients with 2-3 adverse prognostic factors Indeed neither NCVBP regimen LNH87-2 nor ECVBP LNH93-3 led to increase the complete remission rate More recently the addition of etoposide to doxorubicin and cyclophosphamide LNH98-3B did not enhanced the complete remission rate with more toxicity In patients 60 years with 2-3 adverse prognostic factors the complete remission rate remained less than 65 in all these studies Consequently increasing the quality of response remains a major goal in this group of young patients with adverse prognostic factors
It has been shown that the addition of rituximab to CHOP regimen significantly improved the CR rate in elderly patients with previously untreated large B-cell lymphoma when compared with CHOP alone without additional toxicities Moreover event-free survival and overall survival were found to be longer in the R-CHOP group The present trial will evaluate the response rate obtained after four cycles of ACVBP combined to rituximab R-ACVBP before high dose therapy consolidative treatment in this group of higher risk patients
The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell support was beneficial to high risk patients in good response after a full induction phase The long-term results of this randomised study prompted us to consider high dose therapy as the best consolidative option for these patients
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