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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185393
First received: September 12, 2005
Last updated: November 26, 2008
Last verified: November 2008
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and molecular response rates [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Adverse events / Toxicity Grading [ Time Frame: Continous ] [ Designated as safety issue: Yes ]
  • Clinical laboratory results [ Time Frame: 3 monthly ] [ Designated as safety issue: Yes ]
  • Vital signs / physical examination [ Time Frame: 3 monthly ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • Co-medication [ Time Frame: Continous ] [ Designated as safety issue: Yes ]

Enrollment: 414
Study Start Date: August 2001
Study Completion Date: February 2007
Arms Assigned Interventions
Experimental: Arm 1 Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
treatment with 90 Yttrium-labeled anti CD 20 antibody
Arm 2 Other: no treatment
no 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185393

  Show 95 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185393     History of Changes
Other Study ID Numbers: 90966, 304820, NHL FIT
Study First Received: September 12, 2005
Last Updated: November 26, 2008
Health Authority: European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Spain: Ministry of Health
Switzerland: Swissmedic
Germany: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Italy: Ministry of Health
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Norwegian Social Science Data Services
Denmark: Danish Dataprotection Agency
Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bayer:
Follicular Non Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014