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

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
Status
LocationsStatus
Locations

Royal Victoria Hospital

Montreal, Canada, H3A 1A1

Status
Terminated
 
Locations

H:S Rigshospitalet

Copenhagen, Denmark, 2100

Status
Completed
 
Locations

Centre Jean Bernard

Le Mans, France, 72000

Status
Completed
 
Locations

St Bartholomews Hospital

London, United Kingdom, EC1A 7BE

Status
Completed
 
Locations

Universitetssykehuset Nord-Norge

TROMSO, Norway, N-9038

Status
Completed
 
Locations

Instituto Portugues de Oncologia de Francisco Gentil

Porto, Portugal, 4200-072

Status
Completed
 
Locations

UZ Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität zu Köln

Köln, Germany, 50924

Status
Completed
 
Locations

Aarhus Amstsygehus

Aarhus, Denmark, DK-8000

Status
Completed
 
Locations

Institut Català d'Oncologia

Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

Status
Completed
 
Locations

AZ St-Jan Brugge

Brugge, Belgium, 8000

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Completed
 
Locations

Centre Hospitalier Regional Henri Mondor

Creteil, France, 94010

Status
Completed
 
Locations

Royal Victoria Infirmary

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

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Terminated
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Ospedale Santa Chiara

Pisa, Italy, 56126

Status
Completed
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

Status
Completed
 
Locations

Akademiska sjukhuset, Onkologkliniken

Uppsala, Sweden, S-751 85

Status
Terminated
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

University Medical Center Utrecht

Utrecht, Netherlands, 3584 CX

Status
Completed
 
Locations

Det Norske Radiumhospital HF

Oslo, Norway, 0310

Status
Completed
 
Locations

Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000-076

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 41685

Status
Terminated
 
Locations

Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Ospedale Niguarda Ca' Granda

Milano, Italy, 20122

Status
Completed
 
Locations

Norrlands Universitetssjukhus

Umeå, Sweden, 901 85

Status
Completed
 
Locations

CU de Mont-Godinne

Yvoir, Belgium, 5530

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Glasgow Western Infirmary

Glasgow, United Kingdom, G11 6NT

Status
Completed
 
Locations

Instituto Portugues de Oncologia de Francisco Gentil

Lisboa, Portugal, 1070-213

Status
Completed
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

Bruxelles, Belgium, 1000

Status
Completed
 
Locations

Juravinski Cancer Centre-McMaster Medical Unit

Hamilton, Canada, L8V 5C2

Status
Terminated
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2PF

Status
Completed
 
Locations

Policlinico Federico II

Napoli, Italy, 80131

Status
Completed
 
Locations

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Status
Completed
 
Locations

BCCA-Vancouver Cancer Centre

Vancouver, Canada, V5Z 4E6

Status
Completed
 
Locations

Hôpital Cantonal Universitaire de Genève

Geneva, Switzerland, 1211

Status
Terminated
 
Locations

IRCCS Casa Sollievo Sofferenza

San Giovanni Rotondo, Italy, 71013

Status
Completed
 
Locations

Hopital Maisonneuve-Rosemont

Montreal, Canada, H1T 2M4

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

Status
Completed
 
Locations

Academisch Medisch Centrum Universiteit van Amsterdam

Amsterdam, Netherlands

Status
Completed
 
Locations

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland, 6500

Status
Terminated
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01309

Status
Terminated
 
Locations

Hospital Clínico de Salamanca

Salamanca, Spain, 37007

Status
Completed
 
Locations

Centre Léon Bérard

Lyon, France, 69003

Status
Completed
 
Locations

Ospedale S.G. Battista Le Molinette

Torino, Italy, 10126

Status
Completed
 
Locations

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands, 1081 HV

Status
Completed
 
Locations

Bereich Humanmed. d. Georg-August-Universität Göttingen

Göttingen, Germany, 37099

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Centre Henri Becquerel

Rouen, France, 76038

Status
Completed
 
Locations

ZNA Middelheim

Antwerpen, Belgium, 2020

Status
Completed
 
Locations

Asklepios Klinik St. Georg

Hamburg, Germany, 20099

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Terminated
 
Locations

Hopital Necker

paris cedex 15, France, 75743

Status
Completed
 
Locations

Institut Bergonie

Bordeaux, France, 33076

Status
Completed
 
Locations

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Status
Terminated
 
Locations

Istituto Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

Medisch Spectrum Twente, Locatie Ariensplein

Enschede, Netherlands, 7511 JX

Status
Completed
 
Locations

Zentralklinikum Augsburg

Augsburg, Germany, 86156

Status
Completed
 
Locations

Hôpital de Hautepierre

Strasbourg, France, 67098

Status
Completed
 
Locations

Hopital Pontchaillou

Rennes, France, 35038

Status
Completed
 
Locations

IRCCS Ist Europeo Oncologia

Milano, Italy, 20141

Status
Completed
 
Locations

HagaZiekenhuis, locatie Leyenburg

Den Haag, Netherlands, 2545 CH

Status
Terminated
 
Locations

St. Marienhospital Hamm GmbH

Hamm, Germany, 59071

Status
Completed
 
Locations

Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Catharina Ziekenhuis

Eindhoven, Netherlands, 5623 EJ

Status
Completed
 
Locations

Hopital Claude-Huriez CHRU

Lille, France, 59037

Status
Completed
 
Locations

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland, 1011

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Surrey, United Kingdom, SM2 5PT

Status
Terminated
 
Locations

Universitair Medisch Centrum St. Radboud

Nijmegen, Netherlands, 6500 HB

Status
Completed
 
Locations

Kantonsspital Aarau

Aarau, Switzerland, 5000

Status
Terminated
 
Locations

Hospital Virgen de la Victoria

Malaga, Spain, 29010

Status
Completed
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
 
Locations

AUSL 6 Palermo - Sicilia

Palermo, Italy, 90146

Status
Completed
 
Locations

Meander Medisch Centrum

Amersfoort, Netherlands, 3800 BM

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48129

Status
Completed
 
Locations

Centre hospitalier universitaire de Besancon

Besancon, France, 25030

Status
Completed
 
Locations

IRCCS Regina Elena

Roma, Italy, 00144

Status
Completed
 
Locations

Isala Klinieken, Locatie Sophia

Zwolle, Netherlands, 8025 AB

Status
Terminated
 
Locations

Centre Hospitalier Universitaire Bretonneau

Tours, France, 37000

Status
Completed
 
Locations

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6229 HX

Status
Terminated
 
Locations

Centre Hospitalier Universitaire d'Angers

Angers Cedex 1, France, 49033

Status
Completed
 
Locations

Erasmus Medisch Centrum

Rotterdam, Netherlands, 3015 GD

Status
Completed
 
Locations

C.H.U. - Hopital Nord

Grenoble Cedex 9, France, 38043

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 

Trial Design