A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
NCT00269113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2015-07-23
Summary
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.
Conditions
- Non-Hodgkin's Lymphoma
Interventions
- DRUG
-
rituximab [MabThera/Rituxan]
375mg/m2 iv monthly for 8 cycles
- DRUG
-
Standard chemotherapy
As prescribed
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1998-09-30
- Primary Completion
- 2009-04-30
- Completion
- 2009-04-30
Countries
- Germany
Study Locations
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