Velcade in MALT Lymphoma Patients
Phase 2
Completed
- Conditions
- MALT Lymphoma
- Registration Number
- NCT00373906
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method to evaluate the clinical potential of bortezomib to induce objective/histologic responses in patients with MALT-Lymphoma
- Secondary Outcome Measures
Name Time Method to evaluate the impact of bortezomib on progression free survival