Velcade in MALT Lymphoma Patients

Medical University of Vienna16 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

MALT Lymphoma

Interventions

Bortezomib (Velcade)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

to evaluate the clinical potential of bortezomib

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

Secondary Outcomes

to evaluate the impact of bortezomib on progression free survival

Data from ClinicalTrials.gov

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