check_circleStudy Completed

Lymphoma, Non-Hodgkin

Bayer Identifier:

90966

ClinicalTrials.gov Identifier:

NCT00185393

EudraCT Number:

Not Available

EU CT Number:

Not Available
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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
August 2001 - February 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Royal Victoria HospitalMontreal, H3A 1A1, Canada
Completed
H:S RigshospitaletCopenhagen, 2100, Denmark
Completed
Centre Jean BernardLe Mans, 72000, France
Completed
St Bartholomews HospitalLondon, EC1A 7BE, United Kingdom
Completed
Universitetssykehuset Nord-NorgeTROMSO, N-9038, Norway
Completed
Instituto Portugues de Oncologia de Francisco GentilPorto, 4200-072, Portugal
Completed
UZ GentGent, 9000, Belgium
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Medizinische Einrichtungen der Universität zu KölnKöln, 50924, Germany
Completed
Aarhus AmstsygehusAarhus, DK-8000, Denmark
Completed
Institut Català d'OncologiaHospitalet de Llobregat, 08907, Spain
Completed
Centre Hospitalier Lyon SudPierre Benite, 69495, France
Completed
AZ St-Jan BruggeBrugge, 8000, Belgium
Completed
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Completed
Centre Hospitalier Regional Henri MondorCreteil, 94010, France
Completed
Royal Victoria InfirmaryNewcastle-Upon-Tyne, NE1 4LP, United Kingdom
Completed
UZ Leuven GasthuisbergLeuven, 3000, Belgium
Terminated
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Ospedale Santa ChiaraPisa, 56126, Italy
Completed
Leids Universitair Medisch CentrumLeiden, 2333 ZA, Netherlands
Terminated
Akademiska sjukhuset, OnkologklinikenUppsala, S-751 85, Sweden
Completed
Christie HospitalManchester, M20 4BX, United Kingdom
Completed
Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
University Medical Center UtrechtUtrecht, 3584 CX, Netherlands
Completed
Det Norske Radiumhospital HFOslo, 0310, Norway
Completed
Hospitais da Universidade de CoimbraCoimbra, 3000-076, Portugal
Terminated
Sahlgrenska UniversitetssjukhusetGöteborg, 41685, Sweden
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Completed
Klinikum rechts der IsarMünchen, 81675, Germany
Completed
Ospedale Niguarda Ca' GrandaMilano, 20122, Italy
Completed
Norrlands UniversitetssjukhusUmeå, 901 85, Sweden
Completed
CU de Mont-GodinneYvoir, 5530, Belgium
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Completed
Glasgow Western InfirmaryGlasgow, G11 6NT, United Kingdom
Completed
Instituto Portugues de Oncologia de Francisco GentilLisboa, 1070-213, Portugal
Completed
Institut Jules Bordet/Jules Bordet InstituutBruxelles, 1000, Belgium
Terminated
Juravinski Cancer Centre-McMaster Medical UnitHamilton, L8V 5C2, Canada
Completed
Royal Free HospitalLondon, NW3 2PF, United Kingdom
Completed
Policlinico Federico IINapoli, 80131, Italy
Completed
Universitair Medisch Centrum GroningenGroningen, 9713 GZ, Netherlands
Completed
BCCA-Vancouver Cancer CentreVancouver, V5Z 4E6, Canada
Terminated
Hôpital Cantonal Universitaire de GenèveGeneva, 1211, Switzerland
Completed
IRCCS Casa Sollievo SofferenzaSan Giovanni Rotondo, 71013, Italy
Completed
Hopital Maisonneuve-RosemontMontreal, H1T 2M4, Canada
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
Hospital de la Santa Creu i de Sant PauBarcelona, 08025, Spain
Completed
Academisch Medisch Centrum Universiteit van AmsterdamAmsterdam, Netherlands
Completed
Centro Hospitalar de Lisboa Norte - Hospital Santa MariaLisboa, 1649-035, Portugal
Terminated
Istituto Oncologico della Svizzera ItalianaBellinzona, 6500, Switzerland
Terminated
Medizinische Fakultät Carl Gustav CarusDresden, 01309, Germany
Completed
Hospital Clínico de SalamancaSalamanca, 37007, Spain
Completed
Centre Léon BérardLyon, 69003, France
Completed
Ospedale S.G. Battista Le MolinetteTorino, 10126, Italy
Completed
Vrije Universiteit Medisch CentrumAmsterdam, 1081 HV, Netherlands
Completed
Bereich Humanmed. d. Georg-August-Universität GöttingenGöttingen, 37099, Germany
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Centre Henri BecquerelRouen, 76038, France
Completed
ZNA MiddelheimAntwerpen, 2020, Belgium
Completed
Asklepios Klinik St. GeorgHamburg, 20099, Germany
Terminated
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hopital Neckerparis cedex 15, 75743, France
Completed
Institut BergonieBordeaux, 33076, France
Terminated
Derriford HospitalPlymouth, PL6 8DH, United Kingdom
Completed
Istituto Clinico HumanitasRozzano, 20089, Italy
Completed
Medisch Spectrum Twente, Locatie ArienspleinEnschede, 7511 JX, Netherlands
Completed
Zentralklinikum AugsburgAugsburg, 86156, Germany
Completed
Hôpital de HautepierreStrasbourg, 67098, France
Completed
Hopital PontchaillouRennes, 35038, France
Completed
IRCCS Ist Europeo OncologiaMilano, 20141, Italy
Terminated
HagaZiekenhuis, locatie LeyenburgDen Haag, 2545 CH, Netherlands
Completed
St. Marienhospital Hamm GmbHHamm, 59071, Germany
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Completed
Catharina ZiekenhuisEindhoven, 5623 EJ, Netherlands
Completed
Hopital Claude-Huriez CHRULille, 59037, France
Completed
Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, 1011, Switzerland
Terminated
Royal Marsden NHS Trust (Surrey)Surrey, SM2 5PT, United Kingdom
Completed
Universitair Medisch Centrum St. RadboudNijmegen, 6500 HB, Netherlands
Terminated
Kantonsspital AarauAarau, 5000, Switzerland
Completed
Hospital Virgen de la VictoriaMalaga, 29010, Spain
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
Hospital General Universitario Gregorio MarañónMadrid, 28007, Spain
Completed
AUSL 6 Palermo - SiciliaPalermo, 90146, Italy
Completed
Meander Medisch CentrumAmersfoort, 3800 BM, Netherlands
Completed
Universitätsklinikum MünsterMünster, 48129, Germany
Completed
Centre hospitalier universitaire de BesanconBesancon, 25030, France
Completed
IRCCS Regina ElenaRoma, 00144, Italy
Terminated
Isala Klinieken, Locatie SophiaZwolle, 8025 AB, Netherlands
Completed
Centre Hospitalier Universitaire BretonneauTours, 37000, France
Terminated
Academisch Ziekenhuis MaastrichtMaastricht, 6229 HX, Netherlands
Completed
Centre Hospitalier Universitaire d'AngersAngers Cedex 1, 49033, France
Completed
Erasmus Medisch CentrumRotterdam, 3015 GD, Netherlands
Completed
C.H.U. - Hopital NordGrenoble Cedex 9, 38043, France
Completed
Inselspital BernBern, 3010, Switzerland

Primary Outcome

  • Progression free survival
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical and molecular response rates
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    no
  • Overall survival
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    no
  • Quality of Life
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    no
  • Adverse events / Toxicity Grading
    date_rangeTime Frame:
    Continous
    enhanced_encryption
    Safety Issue:
    yes
  • Clinical laboratory results
    date_rangeTime Frame:
    3 monthly
    enhanced_encryption
    Safety Issue:
    yes
  • Vital signs / physical examination
    date_rangeTime Frame:
    3 monthly
    enhanced_encryption
    Safety Issue:
    yes
  • ECG
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    yes
  • Co-medication
    date_rangeTime Frame:
    Continous
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

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