Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Intervention / Treatment
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* Drug: Rituximab and Lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab and Lenalidomide<br>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 | Drug: Rituximab and Lenalidomide<br>* Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of < 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy. | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Severity of Adverse Events | Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population | From treatment start until 28 days after last study treatment; expected study duration 24 months | 
| Influence of Rituximab Plus Lenalidomide on T-cell Subsets | T-cell subsets will be evaluated from EDTA blood in a central lab | Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rituximab, AGMT, MALT Lymphoma, Lenalidomide