Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
NCT ID: NCT00850499
Last Updated: 2012-12-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2009-09-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VELCADE and fludarabine (Group A)
VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
fludarabine
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
VELCADE
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
fludarabine and rituximab (Group B)
fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
fludarabine
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
rituximab
rituximab 375mg/m2 on Day 1 of every 35-day cycle
Interventions
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fludarabine
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
rituximab
rituximab 375mg/m2 on Day 1 of every 35-day cycle
VELCADE
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Eligibility Criteria
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Inclusion Criteria
* Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
* Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
* Documented relapse or progression following last antineoplastic treatment
* At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
Exclusion Criteria
* prior treatment with VELCADE or fludarabine.
* antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
* nitrosoureas within 6 weeks before randomization
* radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
* major surgery within 3 weeks before randomization
* chronic use of corticosteroids, such as dexamethasone
18 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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CHU d'Amiens
Amiens, , France
Institut Bergonie
Bordeaux, , France
CHU Hotel Dieu
Clermont-Ferrand, , France
Centre Victor Hugo
Le Mans, , France
CHU Caremeau
Nîmes, , France
Hoptial Saint Louis
Paris Cedex 10, 75, , France
Hopital Cochin
Paris, 75, Cedex 14, , France
Klinikum Bamberg, fachbereich 3
Bamberg, , Germany
Charite, group Benjamin Franklin
Berlin, , Germany
Hospital Spandau
Berlin, , Germany
Vivantes Klinikum am Urban
Berlin, BE, , Germany
Universitaetsklinikum Frankfurt
Frankfurt, , Germany
Universitatsklinikum Gottingen, zentrum Innere medicin
Göttingen, , 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
Petah 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
Milan, , 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, , Spain
Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
Murcia, , Spain
Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
Salamanca, , Spain
Kantonsspital St.Gallen Department of Oncology/Hematology
Sankt Gallen, , Switzerland
Countries
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Other Identifiers
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26866138-LYM-2033
Identifier Type: -
Identifier Source: org_study_id