Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

• Patients with histologically confirmed MALT lymphoma with measurable disease (stage I - IV)
• With first or greater relapse after HP-eradication, radiation or chemotherapy in case of gastric lymphoma
• Age > 18 years
• Must be able to tolerate therapy, and have adequate cardiac, renal, and hepatic function, ECOG status of 0 - 2
• Must be capable of understanding the purpose of the study and have given written informed consent

Exclusion Criteria:

• Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
• Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
• History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
• Major surgery, other than diagnostic surgery, within the last 4 weeks
• Evidence of CNS involvement
• A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
• Severe peripheral polyneuropathy
• Clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
• Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) \< 1.0 x 109/L
• Patients with active opportunistic infections
• Pregnancy
• Uncontrolled diabetes mellitus
• Preexisting thromboembolic events at start of study