Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129090
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2005-08-10
Brief Title:
Mega-CHOEP Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkins Lymphoma
Sponsor:
German High-Grade Non-Hodgkins Lymphoma Study Group
Organization:
Universität des Saarlandes
Study Overview
Official Title:
A Randomized Phase III Study to Compare Conventional Chemotherapy CHOEP-14 Rituximab vs High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation Mega-CHOEP-21 Rituximab in Younger Patients With Aggressive NHL
Status:
COMPLETED
Status Verified Date:
2023-05
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:
According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma B-NHL and high risk aaIPI 2 or 3 results in a better time to treatment failure TTTF
Detailed Description:
This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose HD therapy program using identical effective drugs at highest possible dose and dose intensity withwithout addition of rituximab initially 4 treatment arms In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20lymphoma
A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems
As the high-dose arm was closed only CD20 B-lymphoma were included past amendment 2
A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems
As the high-dose arm was closed only CD20 B-lymphoma were included past amendment 2
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