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

ID: NCT00185393
Status: Completed
Phase: Phase 3
Start Date: August 01, 2001
First Submitted: September 12, 2005
Last Updated: November 26, 2008
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom
Conditions: Lymphoma, Non-Hodgkin
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Study Description

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.
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 DateSeptember 12, 2005
Last Update Posted DateNovember 26, 2008
Start DateAugust 01, 2001
Actual Completion DateFebruary 01, 2007
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

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

Not Available

Study Design

Brief TitleTreatment 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 TitleEfficacy 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 TypeInterventional
Study PhasePhase 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 MethodN/A
Study PopulationN/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)
Other Arm 2
Other : no treatment

Recruitment Information

Recruitment Status:Completed
Enrollment414
Completion DateFebruary 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
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 CommitteeNo
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 PartyTherapeutic Area Head,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer