Trial information
A Study of MabThera (Rituximab) as Maintenance Therapy in Patients With Aggressive Non-Hodgkin's Lymphoma
Status: Recruiting
Protocol number: ML18223
Sponsor: Roche Austria GmbH
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of MabThera as maintenance therapy compared with treatment-free observation on event-free survival in patients with aggressive B-cell non-Hodgkin's lymphoma
Brief summary: This study will evaluate the efficacy and safety of maintenance therapy with MabThera compared with observation (ie no treatment) in patients with aggressive B-cell non-Hodgkin`s lymphoma who had a complete response following first-line treatment with MabThera plus a chemotherapy regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 600.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Clinical efficacy as measured by event-free survival
Key secondary outcomes: 1. Quality of life, evolution of immunocompetence, safety, and overall survival
Inclusion criteria:
- adult patients >=18 years of age;
- aggressive B-cell non-Hodgkin's lymphoma;
- treatment benefit from prior MabThera plus chemotherapy.
Exclusion criteria:
- first-line NHL therapy other than specified in the inclusion criteria;
- more than one prior chemo- or chemoimmunotherapy regimen;
- history of malignancy other than squamous cell cancer, basal cell cancer of the skin, or in situ cancer of the cervix within the last 5 years;
- active opportunistic infections.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2004
Trial registration date: 08/29/2005
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Argentina
Australia
- Gosford
- Greenslopes
- Hobart
- Sydney
- Wodonga
Austria
- Bludesch
- Bregenz
- Dornbirn
- Fürstenfeld
- Graz
- Hall In Tirol
- Hohenems
- Innsbruck
- Klagenfurt
- Kufstein
- Leoben
- Linz
- Oberpullendorf
- Oberwart
- Ried-Innkreis
- Salzburg
- St Pölten
- Steyr
- Villach
- Vöcklabruck
- Waidhofen A D Thaya
- Wels
- Wien
- Wiener Neustadt
- Zams
Bosnia and Herzegovina
- Banja Luka
- Kasindo
- Sarajevo
Brazil
- Campinas
- Goiania
- Salvador
- Sao Paulo
Bulgaria
- Pleven
- Plovdiv
- Sofia
- Varna
China
Croatia
Czech Republic
- Brno
- Hradec Kralove
- Ostrava
- Praha
Estonia
Israel
- Afula
- Beer Sheva
- Haifa
- Jerusalem
- Kfar Saba
- Petah Tikva
- Ramat Gan
- Rehovot
- Tel Aviv
Latvia
Macedonia, The Former Yugoslav Republic of
Malaysia
Mexico
- Leon
- Mexico City
- Monterrey
- Puebla
Peru
Romania
- Brasov
- Bucharest
- Iasi
- Targu-Mures
Russian Federation
- Belgorod
- Chelyabinsk
- Ekaterinburg
- Irkutsk
- Kazan
- Kirov
- Korolev
- Moscow
- Nizhny Novgorod
- Novosibirsk
- Rostov-Na-Donu
- Saint-Petersburg
- St Petersburg
- Stavropol
- Surgut
- Tumen
- Ufa
- Ulyanovsk
- Volgograd
- Yaroslavl
Slovakia
Slovenia
South Africa
- Pietermaritzburg
- Pretoria
Sweden
- Falun
- Lulea
- Stockholm
- Sundsvall
- Uddevalla
Taiwan
- Kaohsiung
- Taichung
- Taipei
Thailand
- Bangkok
- Chiang Mai
- Khon Kaen
- Songkhla
Turkey
- Ankara
- Aydin
- Eskisehir
- Gaziantep
- Kayseri
