A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT01144364
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- rituximab [Mabthera/Rituxan] — DRUGIntravenous repeating dose
Study Details
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Key Dates
- Start date
- Jan 19, 2004
- Status verified
- Jun 2017
- Primary completion
- Jul 21, 2011
- Completion
- Jul 21, 2011
Study Design
- Enrollment
- 234 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
Primary Outcome Measure
Percentage of Participants With Disease Progression or Death [ Time Frame: 12, 24, and 34 months ]
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