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