A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma

Sponsor
Hoffmann-La Roche
Study ID
NCT00269113
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key Dates

Start date
Sep 30, 1998
Status verified
Jul 2015
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

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

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Percentage of Participants Achieving CR or PR at the End of Therapy [ Time Frame: Following completion of 6 cycles (24 weeks) ]

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