Clinical trial NCT00850499: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Follicular Lymphoma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2009-02-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 18 years or older
* 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:

* Subjects with histological or clinical transformation to an aggressive lymphoma

  * 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

Primary outcomes:
measure: Complete Response Rate
timeFrame: Up to 8 cycles (1 cycle is 35 days: 280 days)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 8 cycles (1 cycle is 35 days: 280 days)
Other outcomes:
Locations:
city: Amiens, 80
country: France
facility: CHU d'Amiens
city: Bordeaux, 33
country: France
facility: Institut Bergonie
city: Clermont Ferrand, 63
country: France
facility: CHU Hotel Dieu
city: Le Mans, 72
country: France
facility: Centre Victor Hugo
city: Nimes, 30
country: France
facility: CHU Caremeau
city: Paris Cedex 10, 75
country: France
facility: Hoptial Saint Louis
city: Paris, 75, Cedex 14
country: France
facility: Hopital Cochin
city: Bamberg
country: Germany
facility: Klinikum Bamberg, fachbereich 3
city: Berlin, BE
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Charite, group Benjamin Franklin
city: Berlin
country: Germany
facility: Hospital Spandau
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Gottingen
country: Germany
facility: Universitatsklinikum Gottingen, zentrum Innere medicin
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein GmbH
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitaetsklinikum Mainz
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
city: Trier
country: Germany
facility: Mutterhaus der Borromaeerinnen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Villingen-Schwenningen
country: Germany
facility: Klinikum der Stadt Villinger-Schwenningen
city: Athens
country: Greece
facility: Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
city: Heraklion- Crete
country: Greece
facility: University Hospital of Heraklion- Department of Hematology
city: Afula
country: Israel
facility: Haemek Medical Center - Hematology Department
city: Haifa
country: Israel
facility: Rambam Med.Center - Hematology Institute
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Hematology Department
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Hematology Institute
city: Ramat Gan
country: Israel
facility: Sheba MC - Hematology Institute
city: Bari
country: Italy
facility: Policlinico di Bari
city: Bologna
country: Italy
facility: Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi
city: Genova
country: Italy
facility: Clinica di Ematologia DIMI - A.O. Ospedale S. Martino
city: Milano
country: Italy
facility: Ospedale Niguarda Ca' Granda
city: Napoli
country: Italy
facility: Azienda Ospedaliera Antonio Cardarelli
city: Pavia
country: Italy
facility: Ospedale Policlinico San Matteo Irccs
city: Pisa
country: Italy
facility: A.O.Univ.Pisana-Osp. Santa Chiara
city: Roma
country: Italy
facility: Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria di Terni
city: Vicenza
country: Italy
facility: Divisione di Ematologia Ospedale San Bortolo - Hematology
city: Cadiz N/a
country: Spain
facility: Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
city: Murcia N/a
country: Spain
facility: Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen Department of Oncology/Hematology
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Medical Monitor
role: STUDY_DIRECTOR
References: