Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas. Primary endpoint: Event-free-survival (EFS) (failure or death from any cause) for all patients. Secondary endpoints: Complete and partial remission rates for all patients Response duration (time to relapse or progression) for responder patients Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients Overall survival for all patients Acute and long-term toxicity

Official Title
-----------------
Multicentric, Non-Randomized Phase 2 Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

Conditions
-----------------
MALT LYMPHOMA

Intervention / Treatment
-----------------
* Drug: Rituximab and Bendamustine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification) Any stage (Ann Arbor I-IV) The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria: Cutaneous lymphoma: recurrent lymphoma after local therapy Gastric lymphoma: b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics). b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy) No evidence of histologic transformation to a high grade lymphoma Measurable or evaluable disease Age >18 and <85 ECOG performance status 0-2 Life expectancy of at least 1 year Written informed consent given according to national/local regulations Exclusion Criteria: Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody Prior radiotherapy in the last 6 weeks Corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms Major impairment of renal function (serum creatinine > 2,5 x upper normal) or liver function (ASAT/ALAT <2,5 x upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement. Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to lymphoma involvement Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement Evidence of symptomatic central nervous system (CNS) disease Active HBV and/or HCV infection Known HIV infection Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule Potential to attend regular visits to the hospital, on an outpatient regimen Hypersensibility to any compound of the study medication. Non appropriate contraceptive method in women of childbearing potential or men Treatment with any drug under research within 30 days previous to start the study medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 Bendamustine<br> | Drug: Rituximab and Bendamustine<br>* Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL |  | 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Include evaluation of the next parameters: Complete and partial remission rates for all patients Response duration for responder patients PFS for all patients Overall survival for all patients Acute and long-term toxicity |  | 2 years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CD 20 positive