Trial information
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Status: No longer recruiting
Protocol number: ML17638
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of MabThera maintenance therapy compared with no further therapy after a brief induction with chemotherapy plus MabThera on failure-free survival in treatment-naïve elderly patients with advanced follicular lymphoma
Brief summary: This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Target sample size is 234.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Placebo; Single Group; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Failure-free survival
Key secondary outcomes: 1. Overall survival, progression-free survival, response rate and duration of response. Incidence of serious and life-threatening AEs
Inclusion criteria:
- adult patients 60-75 years of age;
- B-cell follicular NHL;
- no previous treatment;
- active disease, with rapid progression.
Exclusion criteria:
- other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
- long-term use (>1 month) of systemic corticosteroids;
- central nervous system involvement;
- history of significant cardiovascular disease;
- positive test result for HIV, or hepatitis B or C.
Gender: Males or Females
Age limits: Min: 60 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: January, 2004
Trial registration date: 10/27/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bari
- Bergamo
- Biella
- Bologna
- Bolzano
- Brescia
- Cagliari
- Candiolo
- Catania
- Cremona
- Cuneo
- Firenze
- Milano
- Modena
- Monza
- Napoli
- Orbassano
- Palermo
- Perugia
- Pescara
- Pisa
- Reggio Calabria
- Reggio Emilia
- Roma
- Torino
- Udine
- Verona
