Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00129090|
Recruitment Status : Unknown
Verified September 2015 by Prof. Dr. Norbert Schmitz, German High-Grade Non-Hodgkin's Lymphoma Study Group.
Recruitment status was: Active, not recruiting
First Posted : August 11, 2005
Last Update Posted : September 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma (NHL)||Drug: R-CHOEP 14 with 12x Rituximab||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2003|
|Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2017|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129090
|AK St. Georg|
|Hamburg, Germany, 20099|
|Principal Investigator:||Norbert Schmitz, Prof.||German High-Grade Non-Hodgkin's Lymphoma Study Group|