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

November 26, 2008 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

414

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
      • Brugge, Belgium, 8000
      • Bruxelles, Belgium, 1000
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Yvoir, Belgium, 5530
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
  • Denmark
      • Aarhus, Denmark, DK-8000
      • Copenhagen, Denmark, 2100
  • France
      • Angers Cedex 1, France, 49033
      • Besancon, France, 25030
      • Bordeaux, France, 33076
      • Creteil, France, 94010
      • Grenoble Cedex 9, France, 38043
      • Le Mans, France, 72000
      • Lille, France, 59037
      • Lyon, France, 69003
      • Paris Cedex 15, France, 75743
      • Pierre Benite, France, 69495
      • Rouen, France, 76038
      • Strasbourg, France, 67098
      • Tours, France, 37000
    • Bretagne
      • Rennes, Bretagne, France, 35038
  • Germany
      • Hamburg, Germany, 20099
    • Baden-Wuerttemberg
      • Tübingen, Baden-Wuerttemberg, Germany, 72076
    • Bayern
      • Augsburg, Bayern, Germany, 86156
      • München, Bayern, Germany, 81675
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37099
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Köln, Nordrhein-Westfalen, Germany, 50924
    • Nordrhein-Westfalen / 298
      • Münster, Nordrhein-Westfalen / 298, Germany, 48129
    • Nordrhein-Westfalen / 358
      • Hamm, Nordrhein-Westfalen / 358, Germany, 59071
    • Sachsen
      • Dresden, Sachsen, Germany, 01309
  • Italy
      • Milano, Italy, 20141
      • Napoli, Italy, 80131
      • Palermo, Italy, 90146
      • Roma, Italy, 00144
    • BO
      • Bologna, BO, Italy, 40138
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
    • MI
      • Milano, MI, Italy, 20122
      • Milano, MI, Italy, 20132
      • Rozzano, MI, Italy, 20089
    • PI
      • Pisa, PI, Italy, 56126
    • TO
      • Torino, TO, Italy, 10126
  • Netherlands
      • Amersfoort, Netherlands, 3800 BM
      • Amsterdam, Netherlands
      • Amsterdam, Netherlands, 1081 HV
      • Den Haag, Netherlands, 2545 CH
      • Eindhoven, Netherlands, 5623 EJ
      • Enschede, Netherlands, 7511 JX
      • Groningen, Netherlands, 9713 GZ
      • Leiden, Netherlands, 2333 ZA
      • Maastricht, Netherlands, 6229 HX
      • Nijmegen, Netherlands, 6500 HB
      • Rotterdam, Netherlands, 3015 GD
      • Utrecht, Netherlands, 3584 CX
      • Zwolle, Netherlands, 8025 AB
  • Norway
      • Oslo, Norway, 0310
      • Tromso, Norway, N-9038
  • Portugal
      • Coimbra, Portugal, 3000-076
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1070-213
      • Porto, Portugal, 4200-072
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08025
      • Madrid, Spain, 28040
      • Madrid, Spain, 28007
      • Malaga, Spain, 29010
      • Salamanca, Spain, 37007
      • Valencia, Spain, 46010
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Sweden
      • Göteborg, Sweden, 41685
      • Umeå, Sweden, 901 85
      • Uppsala, Sweden, S-751 85
  • Switzerland
      • Aarau, Switzerland, 5000
      • Bellinzona, Switzerland, 6500
      • Bern, Switzerland, 3010
      • Geneva, Switzerland, 1211
      • Lausanne, Switzerland, 1011
    • Bern / 633
      • Zürich, Bern / 633, Switzerland, 8091
    • St. Gallen / 633
      • St. Gallen, St. Gallen / 633, Switzerland, 9007
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
      • London, United Kingdom, NW3 2PF
      • London, United Kingdom, EC1A 7BE
      • Manchester, United Kingdom, M20 4BX
      • Newcastle-Upon-Tyne, United Kingdom, NE1 4LP
      • Plymouth, United Kingdom, PL6 8DH
      • Surrey, United Kingdom, SM2 5PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: End of study
End of study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 1, 2008

Last Update Submitted That Met QC Criteria

November 26, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90966
  • 304820
  • NHL FIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe