Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

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.

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.

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