Velcade in MALT Lymphoma Patients

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: MALT Lymphoma

Treatments: Drug: Bortezomib (Velcade)

Study type: Interventional

Funder types: Other

Identifiers

NCT00373906

Eudract No 2005-003077-25

Velcade-MALT-Lymphoma

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)