Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Treatments: Lenalidomide; Rituximab; Thalidomide

Criteria

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