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

December 10, 2012 updated by: Millennium Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, 80, France, 80054
        • CHU d'AMIENS
      • Bordeaux, 33, France, 33076
        • Institut Bergonié
      • Clermont Ferrand, 63, France, 63000
        • CHU Hotel Dieu
      • Le Mans, 72, France, 72000
        • Centre Victor Hugo
      • Nimes, 30, France, 30029
        • CHU Caremeau
      • Paris Cedex 10, 75, France, 75475
        • Hoptial Saint Louis
      • Paris, 75, Cedex 14, France, 75679
        • Hôpital Cochin
  • Germany
      • Bamberg, Germany, BY 96049
        • Klinikum Bamberg, fachbereich 3
      • Berlin, Germany, BE 12203
        • Charite, group Benjamin Franklin
      • Berlin, Germany, BE 13585
        • Hospital Spandau
      • Berlin, BE, Germany, 10967
        • Vivantes Klinikum Am Urban
      • Frankfurt, Germany, HE 60590
        • Universitaetsklinikum Frankfurt
      • Gottingen, Germany, NI 37075
        • Universitatsklinikum Gottingen, zentrum Innere medicin
      • Hamm, Germany, NW 50063
        • Evangelisches Krankenhaus Hamm
      • Idar-Oberstein, Germany, RP 55743
        • Klinikum Idar-Oberstein GmbH
      • Jena, Germany, TH 07740
        • Universitaetsklinikum Jena
      • Leipzig, Germany, SN 04103
        • Universitaetsklinikum Leipzig
      • Mainz, Germany, 55131
        • Universitaetsklinikum Mainz
      • Stuttgart, Germany, BW 70376
        • Robert Bosch Krankenhaus
      • Trier, Germany, RP 54290
        • Mutterhaus der Borromaeerinnen
      • Ulm, Germany, BW 89081
        • Universitatsklinikum Ulm
      • Villingen-Schwenningen, Germany, 78050
        • Klinikum der Stadt Villinger-Schwenningen
  • Greece
      • Athens, Greece, 11527
        • Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine
      • Heraklion- Crete, Greece, 71110
        • University Hospital of Heraklion- Department of Hematology
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center - Hematology Department
      • Haifa, Israel, 31096
        • Rambam Med.Center - Hematology Institute
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital - Hematology Department
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center - Hematology Institute
      • Ramat Gan, Israel, 52621
        • Sheba MC - Hematology Institute
  • Italy
      • Bari, Italy
        • Policlinico di Bari
      • Bologna, Italy
        • Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi
      • Genova, Italy
        • Clinica di Ematologia DIMI - A.O. Ospedale S. Martino
      • Milano, Italy
        • Ospedale Niguarda Ca' Granda
      • Napoli, Italy
        • Azienda Ospedaliera Antonio Cardarelli
      • Pavia, Italy
        • Ospedale Policlinico San Matteo Irccs
      • Pisa, Italy
        • A.O.Univ.Pisana-Osp. Santa Chiara
      • Roma, Italy, 00161
        • Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6
      • Terni, Italy
        • Azienda Ospedaliera Santa Maria di Terni
      • Vicenza, Italy
        • Divisione di Ematologia Ospedale San Bortolo - Hematology
  • Spain
      • Cadiz N/a, Spain, 11009
        • Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta
      • Murcia N/a, Spain, 30008
        • Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta
  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen Department of Oncology/Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days)
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.
Up to 8 cycles (1 cycle is 35 days: 280 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Collaborators

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

Investigators

  • Study Director: Medical Monitor, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 10, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26866138-LYM-2033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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