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Completed

NCT Number: NCT00373906

Velcade in MALT Lymphoma Patients

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

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Key information

Conditions

MALT Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bortezomib (Velcade)

Drug

Primary outcomes

  1. to evaluate the clinical potential of bortezomib

  2. to induce objective/histologic responses in patients with MALT-Lymphoma

Secondary outcomes

  1. to evaluate the impact of bortezomib on progression free survival

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

Important dates

First posted
Sep 8, 2006
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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