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Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

This study has been terminated.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00850499
First received: February 24, 2009
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Follicular Lymphoma
Drug: fludarabine
Drug: rituximab
Drug: VELCADE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ] [ Designated as safety issue: No ]
    The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.


Enrollment: 12
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: fludarabine
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
Drug: VELCADE
1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Active Comparator: 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
Drug: fludarabine
fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
Drug: rituximab
rituximab 375mg/m2 on Day 1 of every 35-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850499

  Hide Study Locations
Locations
France
CHU d'Amiens
Amiens, 80, France, 80054
Institut Bergonie
Bordeaux, 33, France, 33076
CHU Hotel Dieu
Clermont Ferrand, 63, France, 63000
Centre Victor Hugo
Le Mans, 72, France, 72000
CHU Caremeau
Nimes, 30, France, 30029
Hoptial Saint Louis
Paris Cedex 10, 75, France, 75475
Hopital Cochin
Paris, 75, Cedex 14, France, 75679
Germany
Klinikum Bamberg, fachbereich 3
Bamberg, Germany, BY 96049
Charite, group Benjamin Franklin
Berlin, Germany, BE 12203
Hospital Spandau
Berlin, Germany, BE 13585
Vivantes Klinikum am Urban
Berlin, BE, Germany, 10967
Universitaetsklinikum Frankfurt
Frankfurt, Germany, HE 60590
Universitatsklinikum Gottingen, zentrum Innere medicin
Gottingen, Germany, NI 37075
Evangelisches Krankenhaus Hamm
Hamm, Germany, NW 50063
Klinikum Idar-Oberstein GmbH
Idar-Oberstein, Germany, RP 55743
Universitaetsklinikum Jena
Jena, Germany, TH 07740
Universitaetsklinikum Leipzig
Leipzig, Germany, SN 04103
Universitaetsklinikum Mainz
Mainz, Germany, 55131
Robert Bosch Krankenhaus
Stuttgart, Germany, BW 70376
Mutterhaus der Borromaeerinnen
Trier, Germany, RP 54290
Universitatsklinikum Ulm
Ulm, Germany, BW 89081
Klinikum der Stadt Villinger-Schwenningen
Villingen-Schwenningen, Germany, 78050
Greece
Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
Athens, Greece, 11527
University Hospital of Heraklion- Department of Hematology
Heraklion- Crete, Greece, 71110
Israel
Haemek Medical Center - Hematology Department
Afula, Israel, 18101
Rambam Med.Center - Hematology Institute
Haifa, Israel, 31096
Hadassah University Hospital - Hematology Department
Jerusalem, Israel, 91120
Rabin Medical Center - Hematology Institute
Petach Tikva, Israel, 49100
Sheba MC - Hematology Institute
Ramat Gan, Israel, 52621
Italy
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, 00161
Azienda Ospedaliera Santa Maria di Terni
Terni, Italy
Divisione di Ematologia Ospedale San Bortolo - Hematology
Vicenza, Italy
Spain
Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
Cadiz N/a, Spain, 11009
Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
Murcia N/a, Spain, 30008
Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
Salamanca, Spain, 37007
Switzerland
Kantonsspital St.Gallen Department of Oncology/Hematology
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Medical Monitor Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00850499     History of Changes
Other Study ID Numbers: 26866138-LYM-2033
Study First Received: February 24, 2009
Results First Received: October 3, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bortezomib
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014