Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
Phase 2
Completed
- Conditions
- MALT Lymphoma
- Registration Number
- NCT00373646
- Lead Sponsor
- Medical University of Vienna
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Department of Internal Medicine I
🇦🇹Vienna, Austria