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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Royal Victoria Hospital Montreal, Canada, H3A 1A1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H:S Rigshospitalet Copenhagen, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Jean Bernard Le Mans, France, 72000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Bartholomews Hospital London, United Kingdom, EC1A 7BE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssykehuset Nord-Norge TROMSO, Norway, N-9038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Portugues de Oncologia de Francisco Gentil Porto, Portugal, 4200-072 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cross Cancer Institute Edmonton, Canada, T6G 1Z2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität zu Köln Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aarhus Amstsygehus Aarhus, Denmark, DK-8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Català d'Oncologia Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Lyon Sud Pierre Benite, France, 69495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ St-Jan Brugge Brugge, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Regional Henri Mondor Creteil, France, 94010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Victoria Infirmary Newcastle-Upon-Tyne, United Kingdom, NE1 4LP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg Leuven, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Santa Chiara Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leids Universitair Medisch Centrum Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska sjukhuset, Onkologkliniken Uppsala, Sweden, S-751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Medical Center Utrecht Utrecht, Netherlands, 3584 CX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Det Norske Radiumhospital HF Oslo, Norway, 0310 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000-076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 41685 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Niguarda Ca' Granda Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Norrlands Universitetssjukhus Umeå, Sweden, 901 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU de Mont-Godinne Yvoir, Belgium, 5530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glasgow Western Infirmary Glasgow, United Kingdom, G11 6NT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Portugues de Oncologia de Francisco Gentil Lisboa, Portugal, 1070-213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Jules Bordet/Jules Bordet Instituut Bruxelles, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Juravinski Cancer Centre-McMaster Medical Unit Hamilton, Canada, L8V 5C2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Free Hospital London, United Kingdom, NW3 2PF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum Groningen Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations BCCA-Vancouver Cancer Centre Vancouver, Canada, V5Z 4E6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Cantonal Universitaire de Genève Geneva, Switzerland, 1211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Casa Sollievo Sofferenza San Giovanni Rotondo, Italy, 71013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Maisonneuve-Rosemont Montreal, Canada, H1T 2M4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Heinrich-Heine-Universität Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Medisch Centrum Universiteit van Amsterdam Amsterdam, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istituto Oncologico della Svizzera Italiana Bellinzona, Switzerland, 6500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico de Salamanca Salamanca, Spain, 37007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Léon Bérard Lyon, France, 69003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale S.G. Battista Le Molinette Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum Amsterdam, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bereich Humanmed. d. Georg-August-Universität Göttingen Göttingen, Germany, 37099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Henri Becquerel Rouen, France, 76038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim Antwerpen, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinik St. Georg Hamburg, Germany, 20099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Necker paris cedex 15, France, 75743 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Bergonie Bordeaux, France, 33076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Derriford Hospital Plymouth, United Kingdom, PL6 8DH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istituto Clinico Humanitas Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Spectrum Twente, Locatie Ariensplein Enschede, Netherlands, 7511 JX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zentralklinikum Augsburg Augsburg, Germany, 86156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de Hautepierre Strasbourg, France, 67098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Pontchaillou Rennes, France, 35038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Europeo Oncologia Milano, Italy, 20141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HagaZiekenhuis, locatie Leyenburg Den Haag, Netherlands, 2545 CH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Marienhospital Hamm GmbH Hamm, Germany, 59071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catharina Ziekenhuis Eindhoven, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Claude-Huriez CHRU Lille, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne, Switzerland, 1011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden NHS Trust (Surrey) Surrey, United Kingdom, SM2 5PT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud Nijmegen, Netherlands, 6500 HB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital Aarau Aarau, Switzerland, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Virgen de la Victoria Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 6 Palermo - Sicilia Palermo, Italy, 90146 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meander Medisch Centrum Amersfoort, Netherlands, 3800 BM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Münster Münster, Germany, 48129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre hospitalier universitaire de Besancon Besancon, France, 25030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Regina Elena Roma, Italy, 00144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Isala Klinieken, Locatie Sophia Zwolle, Netherlands, 8025 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire Bretonneau Tours, France, 37000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Ziekenhuis Maastricht Maastricht, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire d'Angers Angers Cedex 1, France, 49033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erasmus Medisch Centrum Rotterdam, Netherlands, 3015 GD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations C.H.U. - Hopital Nord Grenoble Cedex 9, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Biological/Vaccine
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression free survivalTimeframe: End of study
Secondary Outcome
- Clinical and molecular response ratesTimeframe: End of study
- Overall survivalTimeframe: End of study
- Quality of LifeTimeframe: End of study
- Adverse events / Toxicity GradingTimeframe: Continous
- Clinical laboratory resultsTimeframe: 3 monthly
- Vital signs / physical examinationTimeframe: 3 monthly
- ECGTimeframe: End of study
- Co-medicationTimeframe: Continous
Additional Information
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