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Velcade in MALT Lymphoma Patients

Primary Purpose

MALT Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bortezomib (Velcade)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for MALT Lymphoma focused on measuring MALT Lymphoma, Bortezomib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV)
  • with first or greater relapse after HP-eradication, radiation or chemotherapy ,
  • age > 18 years
  • must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
  • ECOG status of <_ 2
  • must be capable of understanding the purpose of the study and given written informed consent

Sites / Locations

    Outcomes

    Primary Outcome Measures

    to evaluate the clinical potential of bortezomib
    to induce objective/histologic responses in patients with MALT-Lymphoma

    Secondary Outcome Measures

    to evaluate the impact of bortezomib on progression free survival

    Full Information

    First Posted
    September 7, 2006
    Last Updated
    November 26, 2013
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00373906
    Brief Title
    Velcade in MALT Lymphoma Patients
    Official Title
    Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    5. Study Description

    Brief Summary
    Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.
    Detailed Description
    The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation. It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    MALT Lymphoma
    Keywords
    MALT Lymphoma, Bortezomib

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bortezomib (Velcade)
    Primary Outcome Measure Information:
    Title
    to evaluate the clinical potential of bortezomib
    Title
    to induce objective/histologic responses in patients with MALT-Lymphoma
    Secondary Outcome Measure Information:
    Title
    to evaluate the impact of bortezomib on progression free survival

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV) with first or greater relapse after HP-eradication, radiation or chemotherapy , age > 18 years must be able to tolerate therapy and have adequate cardiac, renal and hepatic function ECOG status of <_ 2 must be capable of understanding the purpose of the study and given written informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Markus Raderer, Prof
    Organizational Affiliation
    Department of Internal Medicine I
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19336742
    Citation
    Troch M, Jonak C, Mullauer L, Puspok A, Formanek M, Hauff W, Zielinski CC, Chott A, Raderer M. A phase II study of bortezomib in patients with MALT lymphoma. Haematologica. 2009 May;94(5):738-42. doi: 10.3324/haematol.2008.001537. Epub 2009 Mar 31.
    Results Reference
    derived

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    Velcade in MALT Lymphoma Patients

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