Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Completed; Phase 2

Conditions: Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Treatments: Drug: Rituximab and Lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01611259

AGMT_MALT2

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Rituximab and Lenalidomide

Experimental group

Description:

Single arm: 6 cycles for patients with complete response, 8 cycles for subjects with stable disease or partial remission; cycles duration: 28 days Rituximab (Mabthera®): 375 mg/m² i.v. day 1 Lenalidomide (Revlimid®): 20 mg p.o. daily for 21 days

Treatment:

Drug: Rituximab and Lenalidomide