Trial information
A Study of Long-Term MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma
Status: Recruiting
Protocol number: ML18167
Sponsor: Roche Hungary Ltd.
Company division: Pharmaceutical
Official Scientific Title: Hungarian Study of Maintenance after Rituximab Pre-treatment. A multicenter, open-label study evaluating the long-term effect of MabThera (rituximab) maintenance therapy on event-free survival in patients with advanced follicular lymphoma.
Brief summary: This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with MabThera in patients with advanced follicular lymphoma who have had a positive response to first-line treatment with a MabThera-containing regimen . The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 150.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Single Group; Safety/Efficacy study
Condition: Follicular Lymphoma
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Event-free survival (time to progression, relapse, death, or institution of a new treatment).
Key secondary outcomes: 1. AEs and laboratory assessments
Inclusion criteria:
- adult patients >18 years of age;
- histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment;
- no previous anti-lymphoma treatment before induction chemotherapy (first-line-treated patients only are eligible);
- verified complete or partial remission after first-line induction therapy including MabThera.
Exclusion criteria:
- Grade 3b follicular lymphoma;
- transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma;
- central nervous system lymphoma;
- acquired immunodeficiency syndrome-related lymphoma;
- other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the patient has not been disease-free for >=5 years.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 03/10/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Hungary
- Budapest
- Debrecen
- Gyor
- Gyula
- Kaposvar
- Miskolc
- Nyiregyhaza
- Pecs
- Szeged
- Szekszard
- Szolnok
- Szombathely
- Tatabanya
- Zalaegerszeg
