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
NCT ID: NCT00185393
Last Updated: 2008-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
414 participants
INTERVENTIONAL
2001-08-31
2007-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
treatment with 90 Yttrium-labeled anti CD 20 antibody
Arm 2
no treatment
no treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
treatment with 90 Yttrium-labeled anti CD 20 antibody
no treatment
no treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bayer Schering Pharma AG
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Yvoir, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Aarhus, , Denmark
Copenhagen, , Denmark
Rennes, Brittany Region, France
Angers, , France
Besançon, , France
Bordeaux, , France
Créteil, , France
Grenoble, , France
Le Mans, , France
Lille, , France
Lyon, , France
Paris, , France
Pierre-Bénite, , France
Rouen, , France
Strasbourg, , France
Tours, , France
Tübingen, Baden-Wurttemberg, Germany
Augsburg, Bavaria, Germany
München, Bavaria, Germany
Göttingen, Lower Saxony, Germany
Münster, Nordrhein-Westfalen / 298, Germany
Hamm, Nordrhein-Westfalen / 358, Germany
Cologne, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Hamburg, , Germany
Bologna, BO, Italy
San Giovanni Rotondo, Foggia, Italy
Milan, MI, Italy
Milan, MI, Italy
Rozzano, MI, Italy
Pisa, PI, Italy
Roma, Roma, Italy
Torino, TO, Italy
Milan, , Italy
Napoli, , Italy
Palermo, , Italy
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Eindhoven, , Netherlands
Enschede, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Utrecht, , Netherlands
Zwolle, , Netherlands
Oslo, , Norway
Tromsø, , Norway
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
L'Hospitalet de Llobregat, Barcelona, Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Salamanca, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Zurich, Bern / 633, Switzerland
Sankt Gallen, Saint Gallen / 633, Switzerland
Aarau, , Switzerland
Bellinzona, , Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Plymouth, , United Kingdom
Surrey, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
304820
Identifier Type: -
Identifier Source: secondary_id
NHL FIT
Identifier Type: -
Identifier Source: secondary_id
90966
Identifier Type: -
Identifier Source: org_study_id