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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Bergonie
      • Clermont Ferrand, 63, France, 63000
        • CHU Hôtel 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
        • Universitätsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Millennium Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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