Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

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

This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with Mucosa Associated Lymphoid Tissue (MALT) lymphoma presenting with measurable disease.

Inclusion Criteria selected:

• Histologically verified diagnosis if MALT lymphoma of any localization
• Measurable disease upon diagnosis or first or greater relapse after local therapy, prior chemotherapy orHP-eradication. In addition, also in patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successfulHP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection may be enrolled immediately
• Ann Arbor Stage I-IV
• In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
• ECOG performance status of 0,1 or 2
• Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin

Exclusion Criteria selected:

• 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 or myocardial infarction within the last 6 months
• Known hypersensitivity to thalidomide or lenalidomide or rituximab