Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
18 Years
N/A
Both
MALT Lymphoma
Trial Information
Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
to evaluate the clinical potential of bortezomib
Principal Investigator
Markus Raderer, Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Internal Medicine I
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
Velcade-MALT-Lymphoma
NCT ID:
NCT00373906
Start Date:
Completion Date:
Related Keywords:
- MALT Lymphoma
- MALT Lymphoma, Bortezomib
- Lymphoma
- Lymphoma, B-Cell, Marginal Zone
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