Velcade in MALT Lymphoma Patients

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00373906

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
MALT Lymphoma	Drug: Bortezomib (Velcade)	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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