Trials / Completed
CompletedNCT00430352
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
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.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 545 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rituximab [MabThera/Rituxan] | 375mg/m2 iv every 8 weeks |
Timeline
- Start date
- 2006-09-04
- Primary completion
- 2011-05-26
- Completion
- 2011-05-26
- First posted
- 2007-02-01
- Last updated
- 2017-08-14
- Results posted
- 2015-06-08
Locations
178 sites across 24 countries: Albania, 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)
Source: ClinicalTrials.gov record NCT00430352. Inclusion in this directory is not an endorsement.