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Trial Information
Summary: A Study of MabThera (Rituximab) as Maintenance Therapy in Patients With Aggressive Non-Hodgkin's LymphomaStatus: Recruiting Protocol Number: ML18223 Sponsor: Roche Austria GmbH Company Division: Pharmaceutical Official Scientific Title: A randomized, open-label study of MabThera as maintenance therapy compared with treatment-free observation on event-free survival in patients with aggressive B-cell non-Hodgkin's lymphoma Brief Summary: This study will evaluate the efficacy and safety of maintenance therapy with MabThera compared with observation (ie no treatment) in patients with aggressive B-cell non-Hodgkin`s lymphoma who had a complete response following first-line treatment with MabThera plus a chemotherapy regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 600. Study Phase: IV Study Design / Study Details:
Study Type: Interventional
Condition: Non-Hodgkin's Lymphoma Intervention Type: Drug Intervention Name: rituximab[MabThera/Rituxan] Primary Outcome: 1. Clinical efficacy as measured by event-free survival Key Secondary Outcomes: 1. Quality of life, evolution of immunocompetence, safety, and overall survival Inclusion Criteria:
Exclusion Criteria:
Gender: Males or Females Age Limits: Min: 18 Years Accepts Healthy Volunteers: No Anticipated Start Date: May, 2004 Trial Registration Date: 08/29/2005 Date Last Updated: 09/19/2008
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