Trial information
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
Status: No longer recruiting
Protocol number: ML18324
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of fludarabine and cyclophosphamide plus MabThera followed by maintenance with MabThera on failure-free survival in treatment-naïve patients with advanced indolent B-cell nonfollicular lymphoma
Brief summary: This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Target sample size is 47.
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. Failure-free survival
Key secondary outcomes: 1. Overall survival, disease-free survival, duration of response, response rate; incidence of adverse events
Inclusion criteria:
- adult patients 18-65 years of age;
- previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- active disease;
- >=3 involved sites.
Exclusion criteria:
- typical chronic lymphocytic leukemia;
- other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
- systemic corticosteroid use for >1 month;
- significant cardiovascular disease;
- central nervous system involvement;
- hepatitis B or C virus infection, or HIV infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 10/27/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Brescia
- Firenze
- Messina
- Milano
- Reggio Calabria
- Reggio Emilia
- Rionero in Vulture
- Roma
- Torino
