Trial information
A Study of MabThera (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
Status: Completed
Protocol number: M39006
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: An open-label study of MabThera on objective overall tumor response in treatment-naïve patients with non-bulky follicular non-Hodgkin's lymphoma
Brief summary: This study will evaluate the efficacy and safety of MabThera in treatment-naive patients with non-bulky follicular non-Hodgkin`s lymphoma. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Target sample size is 50.
Study phase: II
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. Clinical efficacy by overall objective complete and partial response rates
Key secondary outcomes: 1. Time to treatment failure, overall survival at 3 years, duration of response, and safety profile; monitoring of the molecular biologic marker bcl2 by polymerase chain reaction assay
Inclusion criteria:
- adult patients 18-75 years of age;
- newly diagnosed non-bulky follicular non-Hodgkin's lymphoma;
- >=1 measurable lesion;
- no prior treatment (no corticosteroids or radiotherapy).
Exclusion criteria:
- transformed follicular lymphoma;
- cerebral or meningeal lymphomaous localization;
- uncontrolled concurrent infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
France
- Angers
- Besancon
- Bordeaux
- Clamart
- Creteil
- Le Mans
- Lyon
- Nantes
- Nice
- Paris
- Pierre Benite
- Poitiers
- Rouen
- Tours
- Vandoeuvre-Les-Nancy
