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: November 26, 2013
Last verified: May 2008
  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:


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
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: 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: November 26, 2013
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

ClinicalTrials.gov processed this record on July 31, 2014