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

This is an interventional treatment trial for MALT Lymphoma focused on measuring MALT lymphoma, Advanced or Helicobacter pylori-refractory MALT lymphoma Read More

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 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