Trial information
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Status: No longer recruiting
Protocol number: MO19872
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A study to evaluate the safety of MabThera (rituximab) maintenance therapy in patients with follicular non-Hodgkin's lymphoma who have responded to induction therapy.
Brief summary: This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. Target sample size is 500.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: 1. Incidence of all, and of grade 3/4, adverse events. Time frame: Throughout study
Key secondary outcomes: 1. PFS, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate. Time frame: Event driven
Inclusion criteria:
- adult patients, >=18 years of age;
- histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
- patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
- demonstrated partial or complete response to induction therapy.
Exclusion criteria:
- stable or progressive disease after most recent induction therapy;
- transformation to high grade lymphoma;
- patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2006
Trial registration date: 07/19/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Albania
Argentina
- Bahia Blanca
- Buenos Aires
- Corrientes
- La Plata
Australia
- Brisbane
- Liverpool
- Perth
- South Brisbane
- Wollongong
Bosnia and Herzegovina
- Banja Luka
- Kasindo
- Mostar
- Sarajevo
Brazil
- Belo Horizonte
- Campinas
- Florianopolis
- Porto Alegre
- Sao Paulo
Bulgaria
Colombia
Croatia
Ecuador
Egypt
Finland
- Haemeenlinna
- Kotka
- Kuopio
- Lahti
- Pori
Germany
- Bad Soden
- Berlin
- Braunschweig
- Duisburg
- Erlangen
- Freiburg
- Gütersloh
- Heidelberg
- Jena
- Lüdenscheid
- Minden
- Mülheim
- München
- Mutlangen
- Oldenburg
- Recklinghausen
- Schwäbisch-Hall
- Stuttgart
- Würselen
Greece
Israel
- Haifa
- Holon
- Jerusalem
- Ramat Gan
- Tel Aviv
Italy
- Aviano
- Bari
- Bologna
- Brescia
- Cagliari
- Candiolo
- Catania
- Ferrara
- Firenze
- Genova
- Lecce
- Milano
- Modena
- Monza
- Napoli
- Novara
- Padova
- Pavia
- Perugia
- Pesaro
- Pescara
- Pisa
- Roma
- Siena
- Torino
- Torrette di Ancona
- Vicenza
Mexico
Romania
- Brasov
- Bucharest
- Cluj-Napoca
- Iasi
- Targu-Mures
Russian Federation
- Belgorod
- Moscow
- Novosibirsk
- Rostov-Na-Donu
- St Petersburg
- Ufa
- Volgograd
- Yaroslavl
Slovakia
- Banska Bystrica
- Bratislava
- Kosice
- Martin
Slovenia
Spain
- Burgos
- Castellon
- El Palmar Murcia
- Jaen
- Leon
- Valencia
Sweden
- Halmstad
- Lulea
- Malmoe
- Sundsvall
- Uddevalla
- Uppsala
Switzerland
Turkey
