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 Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Lymphoma, Non-Hodgkin	Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) Other Names Other: no treatment Other Names	Phase 3

Tracking Information

First Submitted Date	September 12, 2005
Last Update Posted Date	November 26, 2008
Start Date	August 01, 2001
Actual Completion Date	February 01, 2007
Primary Completion Date	N/A
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• Progression free survival [Time Frame: End of study]

Original Primary Outcome Measures

Current Secondary Outcome Measures

• Clinical and molecular response rates [Time Frame: End of study]

• Overall survival [Time Frame: End of study]

• Quality of Life [Time Frame: End of study]

• Adverse events / Toxicity Grading [Time Frame: Continous]

• Clinical laboratory results [Time Frame: 3 monthly]

• Vital signs / physical examination [Time Frame: 3 monthly]

• ECG [Time Frame: End of study]

• Co-medication [Time Frame: Continous]

Original Secondary Outcome Measures

Study Design

Brief Title	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
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
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.
Study Type	Interventional
Study Phase	Phase 3
Estimated Enrollment	414
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None
Primary Purpose	Treatment
Conditions	Lymphoma, Non-Hodgkin
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) treatment with 90 Yttrium-labeled anti CD 20 antibody Other Names Other: no treatment no treatment Other Names
Study Groups/Cohorts	Arm 1 Arm 2
Study Arms	Experimental Arm 1 Biological : Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) treatment with 90 Yttrium-labeled anti CD 20 antibody Other Arm 2 Other : no treatment no treatment

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

Recruitment Information

Recruitment Status:	Completed
Enrollment	414
Completion Date	February 01, 2007
Eligibility Criteria:	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
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Belgium Canada Denmark France Germany Italy Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom

Administrative Information

NCT Number:	NCT00185393
Other Study ID Numbers	90966 304820 NHL FIT
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	Therapeutic Area Head,
Study Sponsor	Bayer
Collaborators	Not Available
Investigators	Study Director Bayer Study Director Bayer