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Brief Title: Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Official Title: A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Study ID: NCT00850499
Brief Summary: This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU d'Amiens, Amiens, 80, , France
Institut Bergonie, Bordeaux, 33, , France
CHU Hotel Dieu, Clermont Ferrand, 63, , France
Centre Victor Hugo, Le Mans, 72, , France
CHU Caremeau, Nimes, 30, , France
Hoptial Saint Louis, Paris Cedex 10, 75, , France
Hopital Cochin, Paris, 75, Cedex 14, , France
Klinikum Bamberg, fachbereich 3, Bamberg, , Germany
Vivantes Klinikum am Urban, Berlin, BE, , Germany
Charite, group Benjamin Franklin, Berlin, , Germany
Hospital Spandau, Berlin, , Germany
Universitaetsklinikum Frankfurt, Frankfurt, , Germany
Universitatsklinikum Gottingen, zentrum Innere medicin, Gottingen, , Germany
Evangelisches Krankenhaus Hamm, Hamm, , Germany
Klinikum Idar-Oberstein GmbH, Idar-Oberstein, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitaetsklinikum Mainz, Mainz, , Germany
Robert Bosch Krankenhaus, Stuttgart, , Germany
Mutterhaus der Borromaeerinnen, Trier, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Klinikum der Stadt Villinger-Schwenningen, Villingen-Schwenningen, , Germany
Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine, Athens, , Greece
University Hospital of Heraklion- Department of Hematology, Heraklion- Crete, , Greece
Haemek Medical Center - Hematology Department, Afula, , Israel
Rambam Med.Center - Hematology Institute, Haifa, , Israel
Hadassah University Hospital - Hematology Department, Jerusalem, , Israel
Rabin Medical Center - Hematology Institute, Petach Tikva, , Israel
Sheba MC - Hematology Institute, Ramat Gan, , Israel
Policlinico di Bari, Bari, , Italy
Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi, Bologna, , Italy
Clinica di Ematologia DIMI - A.O. Ospedale S. Martino, Genova, , Italy
Ospedale Niguarda Ca' Granda, Milano, , Italy
Azienda Ospedaliera Antonio Cardarelli, Napoli, , Italy
Ospedale Policlinico San Matteo Irccs, Pavia, , Italy
A.O.Univ.Pisana-Osp. Santa Chiara, Pisa, , Italy
Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6, Roma, , Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, , Italy
Divisione di Ematologia Ospedale San Bortolo - Hematology, Vicenza, , Italy
Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta, Cadiz N/a, , Spain
Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta, Murcia N/a, , Spain
Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta, Salamanca, , Spain
Kantonsspital St.Gallen Department of Oncology/Hematology, St. Gallen, , Switzerland
Name: Medical Monitor
Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Role: STUDY_DIRECTOR