Velcade in MALT Lymphoma Patients

MALT Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373906
• Other study ID #: Velcade-MALT-Lymphoma
• Secondary ID: Eudract No 2005-
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2006
• Last updated: November 26, 2013

Study information

• Verified date: May 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• MALT Lymphoma

Intervention

Drug:
• Bortezomib (Velcade)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the clinical potential of bortezomib
Primary	to induce objective/histologic responses in patients with MALT-Lymphoma
Secondary	to evaluate the impact of bortezomib on progression free survival