Clinical Trial: Velcade in MALT Lymphoma Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Brief Summary: Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.
Detailed Summary:
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.
Sponsor: Medical University of Vienna
Current Primary Outcome:
- to evaluate the clinical potential of bortezomib
- to induce objective/histologic responses in patients with MALT-Lymphoma
Original Primary Outcome: Same as current
Current Secondary Outcome: to evaluate the impact of bortezomib on progression free survival
Original Secondary Outcome: Same as current
Information By: Medical University of Vienna
Dates:
Date Received: September 7, 2006
Date Started:
Date Completion:
Last Updated: November 26, 2013
Last Verified: May 2008
