Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Efficacy and Safety of Subsequent Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Further Treatment in Patients With Stage III or IV Follicular Non-Hodgkin's Lymphoma Having Achieved Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter, Randomized Phase III Clinical Trial
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.
Status | Completed |
Enrollment | 414 |
Est. completion date | February 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | End of study | No | |
Secondary | Clinical and molecular response rates | End of study | No | |
Secondary | Overall survival | End of study | No | |
Secondary | Quality of Life | End of study | No | |
Secondary | Adverse events / Toxicity Grading | Continous | Yes | |
Secondary | Clinical laboratory results | 3 monthly | Yes | |
Secondary | Vital signs / physical examination | 3 monthly | Yes | |
Secondary | ECG | End of study | Yes | |
Secondary | Co-medication | Continous | Yes |
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