At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 545 enrolled
Drug / intervention
rituximab [MabThera/Rituxan]drug
Likely dose
rituximab [MabThera/Rituxan] 375mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.
In Brief
A Phase 4 clinical trial evaluating rituximab [MabThera/Rituxan] for Non-Hodgkin's Lymphoma. Completed, enrolled 545 participants across 178 sites in 24 countries.
Detailed Summary
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesAlbania, Argentina, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Colombia, Croatia, Ecuador, Egypt, Finland, Germany, Greece, Israel, Italy, Mexico, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye)
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedFeb 2007
Primary CompletionMay 2011
TodayJul 2026
First PostedFeb 1, 2007
Enrollment StartSep 4, 2006
Primary CompletionMay 26, 2011
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 19.4 years ago
Interventions
rituximab [MabThera/Rituxan]drug
375mg/m2 iv every 8 weeks