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
Phase 3
Completed
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)Other: no treatment
- Registration Number
- NCT00185393
- Lead Sponsor
- Bayer
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 414
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) - Arm 2 no treatment -
- Primary Outcome Measures
Name Time Method Progression free survival End of study
- Secondary Outcome Measures
Name Time Method Overall survival End of study Quality of Life End of study ECG End of study Co-medication Continous Clinical and molecular response rates End of study Clinical laboratory results 3 monthly Vital signs / physical examination 3 monthly Adverse events / Toxicity Grading Continous