Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
|Non-Hodgkin's Lymphoma (NHL)||Drug: R-CHOEP 14 with 12x Rituximab||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- time to treatment failure [ Time Frame: 3 years after study inclusion ]At 3 year follow up rate of treatments and time to treatment failure will be determined
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||October 2017|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: R-CHOEP14 with 12x Rituximab
8 cycles of standard CHOP with etoposide in 14-day intervals. Patients with CD20+ lymphoma receive 12 doses of Rituximab (day 0,1,4,8 of cycle 1, day 1 and 8 of cycle 2, day1 of cycle 3-8 )
Drug: R-CHOEP 14 with 12x Rituximab
after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle)
Other Name: 12 x Rituximab with 8 cycles of standard CHOEP-14
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129090
|AK St. Georg|
|Hamburg, Germany, 20099|
|Principal Investigator:||Norbert Schmitz, Prof.||German High-Grade Non-Hodgkin's Lymphoma Study Group|