Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Treatment in Patients With Follicular Non Hodgkin Lymphoma (Stage III or IV) Having Achieved a Partial or Complete Remission After First Line Chemotherapy
NCT00185393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414
Last updated 2008-12-01
Summary
The aim of the study is to test \[90\]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. The radioactive antibody will be compared with no further treatment to see which is better in the long term after standard lymphoma treatment.
Conditions
- Lymphoma, Non-Hodgkin
Interventions
- BIOLOGICAL
-
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
treatment with 90 Yttrium-labeled anti CD 20 antibody
- OTHER
-
no treatment
no treatment
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-08-31
- Completion
- 2007-02-28
Countries
- Belgium
- Canada
- Denmark
- France
- Germany
- Italy
- Netherlands
- Norway
- Portugal
- Spain
- Sweden
- Switzerland
- United Kingdom
Study Locations
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