Spots Global Cancer Trial Database for Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma
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Trial Identification
Brief Title: Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma
Official Title: Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma. The International Extranodal Lymphoma Study Group (IELSG) 36 Phase II Prospective Study
Study ID: NCT02853370
Conditions
Interventions
Study Description
Brief Summary: Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the disease pursues an aggressive course and most patients die of lymphoma progression within 3-4 years. Retrospective studies have indicated that purine analogous achieved very high response rates in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in combination with chemotherapy has been reported to be very effective in producing a rapid clearance of neoplastic cells.
Detailed Description: Prospective, multicenter, open-label, phase II study, designed to determine efficacy and safety of a Chemo-immunotherapy with the combination of bendamustine + rituximab in patients with splenic marginal zone lymphoma. Study Population: previously untreated (except for splenectomy and/or antiviral therapy for Hepatitis C Virus (HCV) infection) and symptomatic Splenic Marginal Zone patients. Objectives: evaluation of the efficacy and the safety of R-Bendamustine in symptomatic Splenic Marginal Zone Lymphoma patients. Primary Objective: efficacy of R-Bendamustine measured by Complete Response rate. Complete response rate defined as regression to normal size on CT of organomegaly (spleen, liver, lymph nodes); normalization of the blood counts and no evidence of circulating clonal cells, and no evidence or minor (≤ 5%) Bone Marrow (BM) infiltration detected by immunohistochemistry (IHC). Treatment: The R-Bendamustine regimen consisted of 28-day cycle. Patients achieving a complete response (CR) after 3 cycles received only one more cycle of R-Bendamustine, while those achieving a partial response (PR) received 3 additional cycles of R-Bendamustine; if less than PR patients were withdrawn from the study
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Créteil (Hôpital Henri Mondor), Creteil, , France
Dijon (CHU de Dijon - Hôpital d'Enfants), Dijon, , France
Grenoble cedex 9 (CHU Michallon), Grenoble, , France
Le Kremlin Bicêtre (Hôpital Bicêtre), Le Kremlin Bicetre, , France
Le Mans (C.H. Le Mans), Le Mans, , France
Lille cedex (CHRU Lille - Hôpital Claude Huriez), Lille, , France
Pierre Bénite, Lyon Sud, , France
Vandoeuvre-les-Nancy cedex (CHU Brabois), Nancy, , France
Nantes cedex 01 (CHU de Nantes - Hôtel Dieu), Nantes, , France
Paris cedex 10 (Hôpital Saint-Louis), Paris, , France
Pessac cedex (Centre François Magendie), Pessac, , France
Rouen (Centre Henri Becquerel), Rouen, , France
Ospedale Civile Ss. Antonio E Biagio, Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona, Ancona, , Italy
Ospedale Armando Businco, Cagliari, , Italy
A.O. Universitaria S. Martino Di Genova, Genova, , Italy
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Sede Di Meldola (Fc), Meldola, , Italy
Irccs Fondazione Centro S. Raffaele Del Monte Tabor, Milano, , Italy
A.O. Universitaria Policlinico Di Modena, Modena, , Italy
A.O. "V. Cervello", Palermo, , Italy
A.O. Universitaria Policlinico Giaccone, Palermo, , Italy
A.O. Universitaria Di Parma, Parma, , Italy
Ausl Di Piacenza, Piacenza, , Italy
Ospedale S. Maria Delle Croci Di Di Ravenna, Ravenna, , Italy
Ospedale Bianchi - Melacrino - Morelli, Reggio Calabria, , Italy
Ospedale Di S. Maria Nuova-Irccs, Reggio Emilia, , Italy
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob), Rionero, , Italy
Irccs Istituto Dermatologico S. Gallicano (Ifo), Roma, , Italy
Azienda Ospedaliera "S. Maria", Terni, , Italy
Ospedale Di Circolo E Fondazione Macchi, Varese, , Italy
Contact Details
Name: Emilio Iannitto, MD
Affiliation: Presidio ospedaliero G. Moscati; UOC di Ematologia - Taranto
Role: STUDY_CHAIR
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