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Velcade in MALT Lymphoma Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00373906
First received: September 7, 2006
Last updated: May 20, 2008
Last verified: May 2008
History of Changes
  Purpose

Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.


Condition Intervention Phase
MALT Lymphoma
 Drug: Bortezomib (Velcade)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

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

Estimated Enrollment: 16
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373906

Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Markus Raderer, Prof Department of Internal Medicine I
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00373906     History of Changes
Other Study ID Numbers: Velcade-MALT-Lymphoma, Eudract No 2005-003077-25
Study First Received: September 7, 2006
Last Updated: May 20, 2008
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
MALT Lymphoma, Bortezomib

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
 Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013