Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140660
Status:
TERMINATED
Last Update Posted:
2017-03-13
First Post:
2005-08-31
Brief Title:
ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Randomized Study of ACVBP Versus ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 65 Years With Low-risk Localized Diffuse Large B-cell Lymphoma Age-adjusted IPI 0
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low acrual
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 R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma
Detailed Description:
Approximately 30 to 40 of diffuse large B cell lymphomas are localized at diagnosis stage I-II Until the seventies radiotherapy was used as the single modality to treat these localized stages but no more than half of the patients were cured From the eighties anthracycline-based regimens combined or not with radiotherapy gave superior results in term of relapse free survival compared with radiotherapy alone Later on Miller et al published a randomized study showing that 3 cycles of CHOP combined with radiotherapy gave superior results in term of overall survival as compared with 8 cycles of CHOP This study was recently updated with a follow up of more than 8 years and shows no more difference between the two arms due to an excess of late mortality after the combined treatment
Recently two trials were conducted by the GELA to compare chemotherapy alone to a combined chemo-radiotherapy approach in patients with low risk localized diffuse large cell lymphoma age-adjusted IPI 0
The objective of the LNH 93-1 study was to compare in patients aged from 18 to 60 years 3 cycles of CHOP followed by radiotherapy with chemotherapy alone consisting in 3 cycles of ACVBP The ACVBP regimen includes a more intensive induction followed by a sequential consolidation With a median follow up of 55 months the results have shown a superiority of the ACVBP arm for both the 5 year event free 83 vs 74 p 0004 and overall survival 89 vs 80 p 002
The LNH 93-4 study compared in patients 60 years the association of 4 cycles of CHOP radiotherapy to the same regimen without irradiation This study fails to demonstrate any benefit of the combined chemo-radiotherapy in term of survival but indicates that chemotherapy alone is probably less toxic in patients older than 69 years
Considering these two trials we concluded that radiotherapy given after chemotherapy did not give any benefit to elderly patients treated for a low risk localized diffuse large cell lymphoma and that ACVBP regimen was superior to 3 CHOP radiotherapy in patients 60 years and has to be considered as the treatment of reference in these patients
Two other GELA trials contributed recently to improve the treatment of diffuse large B cell lymphoma and have to be considered for the elaboration of future studies
The objective of the LNH 98-5 study was to compare the association of CHOP rituximab R-CHOP to the CHOP regimen alone in elderly patients with previously untreated large B-cell lymphoma The analysis showed a significant superiority of the association CHOP rituximab
The LNH 93-5 study compared the ACVBP regimen to the CHOP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index Out of 703 patients included in this study the results have shown the same complete response rate in the two arms but a significantly better 3-year event free survival and overall survival in the ACVBP arm than in the CHOP arm However the benefit seems to be greater in patients 66 years due to higher toxicity with the ACVBP regimen in elderly patients
All the above-mentioned results led us to propose a randomized trial comparing ACVBP to ACVBP rituximab R-ACVBP in previously untreated patients with low risk localized diffuse large B-cell lymphoma age-adjusted IPI 0 and to extend the upper age limit from 60 to 65 years
Recently two trials were conducted by the GELA to compare chemotherapy alone to a combined chemo-radiotherapy approach in patients with low risk localized diffuse large cell lymphoma age-adjusted IPI 0
The objective of the LNH 93-1 study was to compare in patients aged from 18 to 60 years 3 cycles of CHOP followed by radiotherapy with chemotherapy alone consisting in 3 cycles of ACVBP The ACVBP regimen includes a more intensive induction followed by a sequential consolidation With a median follow up of 55 months the results have shown a superiority of the ACVBP arm for both the 5 year event free 83 vs 74 p 0004 and overall survival 89 vs 80 p 002
The LNH 93-4 study compared in patients 60 years the association of 4 cycles of CHOP radiotherapy to the same regimen without irradiation This study fails to demonstrate any benefit of the combined chemo-radiotherapy in term of survival but indicates that chemotherapy alone is probably less toxic in patients older than 69 years
Considering these two trials we concluded that radiotherapy given after chemotherapy did not give any benefit to elderly patients treated for a low risk localized diffuse large cell lymphoma and that ACVBP regimen was superior to 3 CHOP radiotherapy in patients 60 years and has to be considered as the treatment of reference in these patients
Two other GELA trials contributed recently to improve the treatment of diffuse large B cell lymphoma and have to be considered for the elaboration of future studies
The objective of the LNH 98-5 study was to compare the association of CHOP rituximab R-CHOP to the CHOP regimen alone in elderly patients with previously untreated large B-cell lymphoma The analysis showed a significant superiority of the association CHOP rituximab
The LNH 93-5 study compared the ACVBP regimen to the CHOP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index Out of 703 patients included in this study the results have shown the same complete response rate in the two arms but a significantly better 3-year event free survival and overall survival in the ACVBP arm than in the CHOP arm However the benefit seems to be greater in patients 66 years due to higher toxicity with the ACVBP regimen in elderly patients
All the above-mentioned results led us to propose a randomized trial comparing ACVBP to ACVBP rituximab R-ACVBP in previously untreated patients with low risk localized diffuse large B-cell lymphoma age-adjusted IPI 0 and to extend the upper age limit from 60 to 65 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None