THIS IS A CLINICAL STUDY WHICH EVALUATES TREATMENT WITH CHLORAMBUCIL AND RITUXIMAB FOLLOWED BY RITUXIMAB GIVEN UNDER THE SKIN IN PATIENTS WITH A TYPE OF LYMPHOMA CALLED MALT LYMPHOMA

Phase 2

Active, not recruiting

• Conditions: Extranodal Marginal Zone Lymphoma

• Registration Number: 2023-507291-52-00
• Lead Sponsor: Association International Extranodal Lymphoma Study Group (IELSG)

Brief Summary

Aim of the study is to assess the therapeutic safety and activity of the combination of Chlorambucil and Rituximab given for 6 months, followed by 2 years maintenance treatment with subcutaneous Rituximab alone in MALT lymphomas.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-01
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site

Measurable or evaluable disease

Any stage (Ann Arbor I-IV)

Age >= 18

Exclusion Criteria

Evidence of histologic transformation to a high grade lymphoma

Prior chemotherapy

Prior radiotherapy in the last 6 weeks

Prior immunotherapy with any anti-CD20 monoclonal antibody

Known HIV, active Hepatitis B (HB) and Hepatitis C (HC) infections

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Remission rate at the end of induction phase (6 months)		Complete Remission rate at the end of induction phase (6 months)

Secondary Outcome Measures

Name	Time	Method
Response Rate (Complete and partial remission rates) at the end of induction phase ( 6 months from study entry)		Response Rate (Complete and partial remission rates) at the end of induction phase ( 6 months from study entry)
Progression Free Survival		Progression Free Survival
Event-free-survival (EFS) at 5 years		Event-free-survival (EFS) at 5 years
Overall survival		Overall survival
Response duration		Response duration
Acute and long-term toxicity		Acute and long-term toxicity

Trial Locations

Locations (37)

Azienda Ospedaliero Universitaria Delle Marche; 🇮🇹 Ancona, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Azienda Unita Sanitaria Locale Della Romagna; 🇮🇹 Rimini, Italy

Istituto Europeo Di Oncologia S.r.l.; 🇮🇹 Milan, Italy

I.F.O. Istituti Fisioterapici Ospitalieri; 🇮🇹 Rome, Italy

Azienda Ospedaliera S Maria Di Terni; 🇮🇹 Terni, Italy

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino; 🇮🇹 Turin, Italy

Istituto Di Ricovero E Cura A Carattere Scientifico Centro Di Riferimento Oncologico Della Basilicata; 🇮🇹 Rionero In Vulture, Italy

Azienda Unita' Sanitaria Locale Toscana Sud Est; 🇮🇹 Arezzo, Italy

Centro Di Riferimento Oncologico Di Aviano; 🇮🇹 Aviano, Italy

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Azienda Ospedaliero Universitaria Delle Marche

🇮🇹Ancona, Italy

Guido Gini

Site contact

+390715964562

guido.gini@ospedaliriuniti.marche.it