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Clinical Trial 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)


Clinical Trial 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 with/without 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 CD20+lymphoma. 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 Design


Related Conditions & MeSH terms


NCT number NCT00129090
Study type Interventional
Source Universität des Saarlandes
Contact
Status Completed
Phase Phase 3
Start date March 2003
Completion date October 2017

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