Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial...
Eligibility Criteria
Inclusion
- Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
- Patients who have achieved a remission after first line chemotherapy
- No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
- older than 18 years
- written informed consent
Exclusion
- Any other anticancer treatment for NHL except the preceding first line chemotherapy
- Prior radiation therapy
- Patients who have not recovered from the toxic effects of the first line chemotherapy
- Any other cancer or history of cancer less than 10 years ago
- Patients with known HIV positivity
- patients with pleural effusion or ascites
- female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
- Adults not employing an effective method of birth control during study treatment and 12 months thereafter
- Patients unable or unwilling to comply with protocol
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT00185393
Start Date
August 1 2001
End Date
February 1 2007
Last Update
December 1 2008
Active Locations (95)
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1
Antwerp, Belgium, 2020
2
Bruges, Belgium, 8000
3
Brussels, Belgium, 1000
4
Ghent, Belgium, 9000