Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
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
1 other identifier
interventional
12
7 countries
43
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2009
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
November 1, 2012
CompletedDecember 12, 2012
December 1, 2012
2 years
February 24, 2009
October 3, 2012
December 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response Rate
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Up to 8 cycles (1 cycle is 35 days: 280 days)
Secondary Outcomes (1)
Overall Response Rate
Up to 8 cycles (1 cycle is 35 days: 280 days)
Study Arms (2)
VELCADE and fludarabine (Group A)
EXPERIMENTALVELCADE 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 and rituximab (Group B)
ACTIVE COMPARATORfludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
Interventions
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
CHU d'Amiens
Amiens, 80054, France
Institut Bergonie
Bordeaux, 33076, France
CHU Hotel Dieu
Clermont-Ferrand, 63000, France
Centre Victor Hugo
Le Mans, 72000, France
CHU Caremeau
Nîmes, 30029, France
Hoptial Saint Louis
Paris Cedex 10, 75, 75475, France
Hopital Cochin
Paris, 75, Cedex 14, 75679, France
Klinikum Bamberg, fachbereich 3
Bamberg, BY 96049, Germany
Charite, group Benjamin Franklin
Berlin, BE 12203, Germany
Hospital Spandau
Berlin, BE 13585, Germany
Vivantes Klinikum am Urban
Berlin, BE, 10967, Germany
Universitaetsklinikum Frankfurt
Frankfurt, HE 60590, Germany
Universitatsklinikum Gottingen, zentrum Innere medicin
Göttingen, NI 37075, Germany
Evangelisches Krankenhaus Hamm
Hamm, NW 50063, Germany
Klinikum Idar-Oberstein GmbH
Idar-Oberstein, RP 55743, Germany
Universitaetsklinikum Jena
Jena, TH 07740, Germany
Universitaetsklinikum Leipzig
Leipzig, SN 04103, Germany
Universitaetsklinikum Mainz
Mainz, 55131, Germany
Robert Bosch Krankenhaus
Stuttgart, BW 70376, Germany
Mutterhaus der Borromaeerinnen
Trier, RP 54290, Germany
Universitatsklinikum Ulm
Ulm, BW 89081, Germany
Klinikum der Stadt Villinger-Schwenningen
Villingen-Schwenningen, 78050, Germany
Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
Athens, 11527, Greece
University Hospital of Heraklion- Department of Hematology
Heraklion- Crete, 71110, Greece
Haemek Medical Center - Hematology Department
Afula, 18101, Israel
Rambam Med.Center - Hematology Institute
Haifa, 31096, Israel
Hadassah University Hospital - Hematology Department
Jerusalem, 91120, Israel
Rabin Medical Center - Hematology Institute
Petah Tikva, 49100, Israel
Sheba MC - Hematology Institute
Ramat Gan, 52621, 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, 00161, 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, 11009, Spain
Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
Murcia, 30008, Spain
Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
Salamanca, 37007, Spain
Kantonsspital St.Gallen Department of Oncology/Hematology
Sankt Gallen, 9007, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed
Results Point of Contact
- Title
- Andrew Cakana, MD, FRC Path
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Medical Monitor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 25, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
December 12, 2012
Results First Posted
November 1, 2012
Record last verified: 2012-12