Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355199
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2006-07-20
Brief Title:
Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL
Sponsor:
Gruppo Italiano Terapie Innovative nei Linfomi
Organization:
Gruppo Italiano Terapie Innovative nei Linfomi
Study Overview
Official Title:
Multicentric Randomized Phase III Study Comparing High Doses of Chemotherapy With Rituximab Followed by Auto-transplant HPC Versus CHOP Plus Rituximab as First Line Therapy in High Risk Patients With DLBCL Non-Hodgkins Lymphomas
Status:
COMPLETED
Status Verified Date:
2017-08
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:
Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk patients with DLBCL Non-Hodgkins lymphomas
Detailed Description:
Diffuse large B cells Non-Hodgkins lymphomas represents one of the most frequent form of lymphoma Its clinical development progresses rapidly and is characterized by a biphasic survival curve with patients in complete remission which can be considered cured and patients that relapse This last group of subjects have only 25-33 chance of long free disease survival if treated with a second line therapy with high dose chemotherapy plus autologous transplant of PBPC
Therefore in order to achieve an improvement of the overall survival in patient with DLBCL it is necessary to increase the number of complete remission after first line therapy
The aim of R-HDS study multicentre randomized phase III trial is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy R-HDS plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis
Therefore in order to achieve an improvement of the overall survival in patient with DLBCL it is necessary to increase the number of complete remission after first line therapy
The aim of R-HDS study multicentre randomized phase III trial is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy R-HDS plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis
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