MALT Lymphoma
Conditions
Keywords
MALT Lymphoma, thalidomide, disseminated MALT Lymphoma or at relapse following HP-eradication, or chemotherapy or radiation
Brief summary
The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or radiation.
Detailed description
The objectives of this study are to evaluate the effectivity and the safety of thalidomide 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 size of 16 patients. Thalidomide is given orally at an initial dose of 100 mg for a maximum duration of 6 months.
Interventions
DRUGThalidomide, Pharmion
200 mg p.o. daily
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 * Must be able to tolerate therapy and have adequate cardiac, renal and hepatic function * ECOG status \_\< 2 * Must be capable of understanding the purpose of the study and have given written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of thalidomide in this patient population and to evaluate | 6 months |
| The impact of thalidomide on progression free survival | 12 months |
Countries
Austria
Outcome results
None listed