Trial information
A Study of MabThera (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
Status: Completed
Protocol number: M39004
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: Clinical response in patients with relapsed centroblastic centrocytic non-Hodgkin's lymphoma after treatment with anti-CD20 antibody IDEC C2B8 (MabThera)
Brief summary: This study will evaluate the efficacy and safety of MabThera in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin`s lymphoma. Patients will receive once-weekly intravenous MabThera for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 30.
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. Efficacy: clinical response (complete or partial remission), duration of response. Safety: adverse events, laboratory test results, and vital signs.
Key secondary outcomes: 1. Efficacy of re-treatment of responding patients, in case of disease progression
Inclusion criteria:
- adult patients >= 18 years of age;
- centrocytic centroblastic non-Hodgkin`s lymphoma stage III-IV;
- relapse after chemotherapy (with or without interferon maintenance therapy).
Exclusion criteria:
- primary refractory lymphomas;
- more than 3 relapses of centroblastic centrocytic non-Hodgkin`s lymphoma;
- clinically significant cardiac disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
