Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135499
Status:
TERMINATED
Last Update Posted:
2018-08-23
First Post:
2005-08-25
Brief Title:
R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment too low
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the efficacy of doxorubicin cyclophosphamide vindesine bleomycin and prednisone ACVBP plus rituximab in comparison to cyclophosphamide doxorubicin vincristine prednisone CHOP plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival The goal is to obtain a 10 increase of event-free survival at 3 years
Detailed Description:
In Europe 50 or more of new non-Hodgkin lymphoma cases occur in patients older than 60 years More than 30 are diffuse large B-cell lymphomas DLCL
The CHOP chemotherapy cyclophosphamide doxorubicin vincristine prednisone was considered as the standard treatment in this population Nevertheless this treatment is associated with some toxic events in elderly patients and it did does not succeed to increase the 3-year survival rate above 40
Two trials in patients above 60 years with DLCL cases were conducted by the GELA in the aim to improve the results of CHOP
Protocol LNH 93-5 The primary objective of this study was to compare CHOP to ACVBP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index
Unlike the CHOP regimen the ACVBP regimen includes a more intensive induction followed by a sequential consolidation with drugs different from those used during the induction phase and includes a prevention of neuromeningeal relapses
Out of 708 patients included in this study the results have shown that
Complete response rate was the same in the two arms
Event free survival was significantly better in the ACVBP arm than the CHOP arm 5-year survival rate 39 versus 29 p0005
Overall survival was significantly better in the ACVBP arm than in the CHOP arm the 5-year survival rate 46 versus 38 p0036
The ACVBP regimen was more toxic than the CHOP regimen particularly in elderly patients 65 years and in patients with a low performance status
Prevention of neuromeningeal relapses was necessary for these patients
Protocol LNH 98-5 the objective of this study was to compare the association CHOP rituximab R-CHOP to the CHOP regimen alone in elderly patients with non previously treated diffuse large B-cell lymphoma
Long-term results based on data from 399 patients with a median follow-up of 5 years were as follows
Complete response rate was better in the R-CHOP arm than in the CHOP arm 76 versus 61 p0005
Significant prolongation of event-free survival p00002 and overall survival p00073 in the R-CHOP arm
No significant difference between the two arms in terms of toxicity R-CHOP is now considered worldwide as the standard combination for these patients
These conclusions invited us to propose a randomized trial comparing ACVBP rituximab to CHOP rituximab The study population is limited to patients aged from 60 to 65 years
The CHOP chemotherapy cyclophosphamide doxorubicin vincristine prednisone was considered as the standard treatment in this population Nevertheless this treatment is associated with some toxic events in elderly patients and it did does not succeed to increase the 3-year survival rate above 40
Two trials in patients above 60 years with DLCL cases were conducted by the GELA in the aim to improve the results of CHOP
Protocol LNH 93-5 The primary objective of this study was to compare CHOP to ACVBP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index
Unlike the CHOP regimen the ACVBP regimen includes a more intensive induction followed by a sequential consolidation with drugs different from those used during the induction phase and includes a prevention of neuromeningeal relapses
Out of 708 patients included in this study the results have shown that
Complete response rate was the same in the two arms
Event free survival was significantly better in the ACVBP arm than the CHOP arm 5-year survival rate 39 versus 29 p0005
Overall survival was significantly better in the ACVBP arm than in the CHOP arm the 5-year survival rate 46 versus 38 p0036
The ACVBP regimen was more toxic than the CHOP regimen particularly in elderly patients 65 years and in patients with a low performance status
Prevention of neuromeningeal relapses was necessary for these patients
Protocol LNH 98-5 the objective of this study was to compare the association CHOP rituximab R-CHOP to the CHOP regimen alone in elderly patients with non previously treated diffuse large B-cell lymphoma
Long-term results based on data from 399 patients with a median follow-up of 5 years were as follows
Complete response rate was better in the R-CHOP arm than in the CHOP arm 76 versus 61 p0005
Significant prolongation of event-free survival p00002 and overall survival p00073 in the R-CHOP arm
No significant difference between the two arms in terms of toxicity R-CHOP is now considered worldwide as the standard combination for these patients
These conclusions invited us to propose a randomized trial comparing ACVBP rituximab to CHOP rituximab The study population is limited to patients aged from 60 to 65 years
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