Trial Condition(s):

Lymphoma, Non-Hodgkin

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

Bayer Identifier:

90966

ClinicalTrials.gov Identifier:

NCT00185393

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
414
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Royal Victoria Hospital

Montreal, Canada, H3A 1A1

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H:S Rigshospitalet

Copenhagen, Denmark, 2100

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Centre Jean Bernard

Le Mans, France, 72000

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St Bartholomews Hospital

London, United Kingdom, EC1A 7BE

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Universitetssykehuset Nord-Norge

TROMSO, Norway, N-9038

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Instituto Portugues de Oncologia de Francisco Gentil

Porto, Portugal, 4200-072

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UZ Gent

Gent, Belgium, 9000

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Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

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Medizinische Einrichtungen der Universität zu Köln

Köln, Germany, 50924

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Aarhus Amstsygehus

Aarhus, Denmark, DK-8000

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Institut Català d'Oncologia

Hospitalet de Llobregat, Spain, 08907

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Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

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AZ St-Jan Brugge

Brugge, Belgium, 8000

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Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

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Centre Hospitalier Regional Henri Mondor

Creteil, France, 94010

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Royal Victoria Infirmary

Newcastle-Upon-Tyne, United Kingdom, NE1 4LP

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UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

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Universitätsspital Zürich

Zürich, Switzerland, 8091

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Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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Ospedale Santa Chiara

Pisa, Italy, 56126

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Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

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Akademiska sjukhuset, Onkologkliniken

Uppsala, Sweden, S-751 85

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Christie Hospital

Manchester, United Kingdom, M20 4BX

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Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

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University Medical Center Utrecht

Utrecht, Netherlands, 3584 CX

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Det Norske Radiumhospital HF

Oslo, Norway, 0310

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Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-076

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Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 41685

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Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

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Klinikum rechts der Isar

München, Germany, 81675

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Ospedale Niguarda Ca' Granda

Milano, Italy, 20122

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Norrlands Universitetssjukhus

Umeå, Sweden, 901 85

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CU de Mont-Godinne

Yvoir, Belgium, 5530

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Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

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Glasgow Western Infirmary

Glasgow, United Kingdom, G11 6NT

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Instituto Portugues de Oncologia de Francisco Gentil

Lisboa, Portugal, 1070-213

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Institut Jules Bordet/Jules Bordet Instituut

Bruxelles, Belgium, 1000

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Juravinski Cancer Centre-McMaster Medical Unit

Hamilton, Canada, L8V 5C2

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Royal Free Hospital

London, United Kingdom, NW3 2PF

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Policlinico Federico II

Napoli, Italy, 80131

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Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

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BCCA-Vancouver Cancer Centre

Vancouver, Canada, V5Z 4E6

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Hôpital Cantonal Universitaire de Genève

Geneva, Switzerland, 1211

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IRCCS Casa Sollievo Sofferenza

San Giovanni Rotondo, Italy, 71013

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Hopital Maisonneuve-Rosemont

Montreal, Canada, H1T 2M4

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Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

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Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

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Academisch Medisch Centrum Universiteit van Amsterdam

Amsterdam, Netherlands

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Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisboa, Portugal, 1649-035

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Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland, 6500

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Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01309

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Hospital Clínico de Salamanca

Salamanca, Spain, 37007

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Centre Léon Bérard

Lyon, France, 69003

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Ospedale S.G. Battista Le Molinette

Torino, Italy, 10126

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Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands, 1081 HV

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Bereich Humanmed. d. Georg-August-Universität Göttingen

Göttingen, Germany, 37099

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Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

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Centre Henri Becquerel

Rouen, France, 76038

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ZNA Middelheim

Antwerpen, Belgium, 2020

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Asklepios Klinik St. Georg

Hamburg, Germany, 20099

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Hopital Necker

paris cedex 15, France, 75743

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Institut Bergonie

Bordeaux, France, 33076

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Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

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Istituto Clinico Humanitas

Rozzano, Italy, 20089

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Medisch Spectrum Twente, Locatie Ariensplein

Enschede, Netherlands, 7511 JX

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Zentralklinikum Augsburg

Augsburg, Germany, 86156

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Hôpital de Hautepierre

Strasbourg, France, 67098

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Hopital Pontchaillou

Rennes, France, 35038

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IRCCS Ist Europeo Oncologia

Milano, Italy, 20141

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HagaZiekenhuis, locatie Leyenburg

Den Haag, Netherlands, 2545 CH

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St. Marienhospital Hamm GmbH

Hamm, Germany, 59071

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Ospedale San Raffaele

Milano, Italy, 20132

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Catharina Ziekenhuis

Eindhoven, Netherlands, 5623 EJ

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Hopital Claude-Huriez CHRU

Lille, France, 59037

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Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland, 1011

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Royal Marsden NHS Trust (Surrey)

Surrey, United Kingdom, SM2 5PT

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Universitair Medisch Centrum St. Radboud

Nijmegen, Netherlands, 6500 HB

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Kantonsspital Aarau

Aarau, Switzerland, 5000

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Hospital Virgen de la Victoria

Malaga, Spain, 29010

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Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

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Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

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AUSL 6 Palermo - Sicilia

Palermo, Italy, 90146

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Meander Medisch Centrum

Amersfoort, Netherlands, 3800 BM

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Universitätsklinikum Münster

Münster, Germany, 48129

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Centre hospitalier universitaire de Besancon

Besancon, France, 25030

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IRCCS Regina Elena

Roma, Italy, 00144

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Isala Klinieken, Locatie Sophia

Zwolle, Netherlands, 8025 AB

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Centre Hospitalier Universitaire Bretonneau

Tours, France, 37000

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Academisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6229 HX

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Centre Hospitalier Universitaire d'Angers

Angers Cedex 1, France, 49033

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Erasmus Medisch Centrum

Rotterdam, Netherlands, 3015 GD

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C.H.U. - Hopital Nord

Grenoble Cedex 9, France, 38043

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Inselspital Bern

Bern, Switzerland, 3010

Trial Design