Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

Sponsor
Jurgen Barth
Study ID
NCT00877214
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Follicular Lymphomas
  • Immunocytomas
  • Lymphocytic Lymphoma
  • Mantle-Cell Lymphomas
  • Marginal Zone Lymphomas
  • Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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
  • Rituximab / observation — DRUG
    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)

Study Details

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.

Key Dates

Start date
Apr 1, 2009
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
1,272 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Follicular Lymphomas: Rituximab 375 mg/m² for additional 2 years after 2 years of standard maintainance All other lymphomas: Rituximab 375 mg/m² for 2 years as maintainance. From 2014 only Morbus Waldenstroem: Rituximab 1.400 mg absolute s. c. injection
  • Active Comparator: Standard
    Rituximab / Observation

Primary Outcome Measure

Progression free survival [ Time Frame: 5 years and ongoing ]

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