Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma (nhl)
Treatment r-choep 14 with 12x rituximab
Phase phase 3
Sponsor German High-Grade Non-Hodgkin's Lymphoma Study Group
Collaborator Deutsche Krebshilfe e.V., Bonn (Germany)
Start date March 2003
End date October 2014
Trial size 450 participants
Trial identifier NCT00129090, DSHNHL 2002-1

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 )
r-choep 14 with 12x rituximab 12 x Rituximab with 8 cycles of standard CHOEP-14
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)

Primary Outcomes

Measure
time to treatment failure
time frame: 3 years after study inclusion

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - 18-60 years of age - Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted) - Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3 - Patient's written informed consent - Aggressive non-Hodgkin's lymphoma with CD20+ histology Exclusion Criteria: - Already initiated lymphoma therapy - Serious accompanying disorder or impaired organ function - Bone marrow involvement > 25% - Known hypersensibility to the medications to be used - Known HIV-positivity - Active hepatitis infection - Suspicion that patient compliance will be poor - Simultaneous participation in other trials - Prior chemo- or radiotherapy for previous disorder - Other concomitant tumour disease

Additional Information

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
Principal investigator Norbert Schmitz, Prof.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by German High-Grade Non-Hodgkin's Lymphoma Study Group.