Lymphoma, Non-Hodgkin
Conditions
Keywords
Follicular Non Hodgkin lymphoma
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.
Interventions
BIOLOGICALZevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
treatment with 90 Yttrium-labeled anti CD 20 antibody
OTHERno treatment
no treatment
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | End of study |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | End of study |
| Quality of Life | End of study |
| Adverse events / Toxicity Grading | Continous |
| Clinical and molecular response rates | End of study |
| Vital signs / physical examination | 3 monthly |
| ECG | End of study |
| Co-medication | Continous |
| Clinical laboratory results | 3 monthly |
Countries
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed