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Spots Global Cancer Trial Database for Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Monitor

Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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