Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

Sponsor
University of Giessen
Study ID
NCT01456351
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.

Key Dates

Start date
Sep 30, 2003
Status verified
Aug 2024
Primary completion
Aug 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
230 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine plus Rituximab
    Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
  • Active Comparator: Fludarabine plus Rituximab
    Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w

Primary Outcome Measure

Event Free Survival [ Time Frame: Observation till event or death, minimum 1 year ]

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