MALT Lymphoma
Conditions
Keywords
MALT Lymphoma, Bortezomib
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.
Interventions
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the clinical potential of bortezomib | — |
| to induce objective/histologic responses in patients with MALT-Lymphoma | — |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the impact of bortezomib on progression free survival | — |
Outcome results
None listed