Trials / Active Not Recruiting
Active Not RecruitingNCT00877214
Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas
Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,272 (actual)
- Sponsor
- Jurgen Barth · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.
Detailed description
Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated. This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.
Conditions
- Follicular Lymphomas
- Immunocytomas
- Marginal Zone Lymphomas
- Mantle-Cell Lymphomas
- Lymphocytic Lymphoma
- Non-Hodgkin's Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years |
| DRUG | Rituximab / observation | Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard) |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2009-04-07
- Last updated
- 2024-08-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00877214. Inclusion in this directory is not an endorsement.