Trial information
A Study of MabThera (Rituximab) in Combination With a Standard Chemotherapy Regimen in Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Status: Completed
Protocol number: M39045
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of adding MabThera to a CHOP-like chemotherapy regimen on time to treatment failure and safety in treatment-naïve patients with diffuse large B-cell non-Hodgkin's lymphoma
Brief summary: This study will assess the safety and efficacy of adding MabThera to chemotherapy as first-line treatment for patients with diffuse large B-cell non-Hodgkin`s lymphoma. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.
Target sample size is 820.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Efficacy: Time to treatment failure.
Key secondary outcomes: 1. Efficacy: Complete remission rate, survival, tumor control, disease-free survival, and progression rate. Safety: Adverse events.
Inclusion criteria:
- adult patients 18-60 years of age;
- untreated CD20-positive diffuse large B-cell non-Hodgkin's lymphoma.
Exclusion criteria:
- participation in another clinical trial during the last 12 weeks;
- secondary lymphoma after previous chemotherapy or radiotherapy for other malignancies;
- previous lymphoma-specific treatment;
- women who are pregnant or lactating;
- women of childbearing potential who are not using reliable contraception.
Gender: Males or Females
Age limits: Min: 18 Years Max: 60 Years
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Ballarat
- Brisbane
- Canberra
- Darlinghurst
- Fitzroy
- Frankston
- Fremantle
- Geelong
- Gosford
- Heidelberg
- Hobart
- Melbourne
- Newcastle
- Parkville
- Perth
- St. Leonards
- Sydney
- Townsville
- Wodonga
- Wollongong
- Woolloongabba
Austria
Brazil
Canada
Czech Republic
Denmark
Finland
France
- La Roche Sur Yon
- Neuilly-Sur-Seine
- Tours
Germany
- Augsburg
- Berlin
- Cottbus
- Dortmund
- Düsseldorf
- Erfurt
- Frankfurt Am Main
- Goettingen
- Göttingen
- Greifswald
- Grenzach-Wyhlen
- Hagen
- Hamburg
- Hannover
- Heidelberg
- Homburg
- Jena
- Kiel
- Koeln
- Leipzig
- Ludwigshafen
- Magdeburg
- Marburg
- Minden
- Mönchengladbach
- München
- Münster
- Oldenburg
- Regensburg
- Stuttgart
- Trier
- Ulm
- Villingen-Schwenningen
- Wiesbaden
Israel
Italy
Norway
Poland
- Gdansk
- Gliwice
- Katowice
- Lodz
- Lublin
- Warszawa
- Wroclaw
Spain
Sweden
Switzerland
- Aarau
- Basel
- Bellinzona
- Bern
- Reinach
- St Gallen
- Zürich
United Kingdom
- Aberdeen
- Belfast
- Birmingham
- Blackpool
- Bristol
- Cambridge
- Cardiff
- Leeds
- Leicester
- Liverpool
- London
- Newcastle upon Tyne
- Northwood
- Norwich
- Nottingham
- Oxford
- Preston
- Sheffield
- Southampton
- Sutton
