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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
* Other: no treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)<br>* treatment with 90 Yttrium-labeled anti CD 20 antibody<br>|
| Other: Arm 2<br> | Other: no treatment<br>* no treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and molecular response rates |  | End of study | 
| Overall survival |  | End of study | 
| Quality of Life |  | End of study | 
| Adverse events / Toxicity Grading |  | Continous | 
| Clinical laboratory results |  | 3 monthly | 
| Vital signs / physical examination |  | 3 monthly | 
| ECG |  | End of study | 
| Co-medication |  | Continous | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular Non Hodgkin lymphoma