Spots Global Cancer Trial Database for Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's
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Trial Identification
Brief Title: Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's
Official Title: Fase II Study With Bortezomib, Rituximab and Bendamustin-BRB- for Non-Hodgkin Lymphoplasmocytic Lymphoma/Waldenstrom Macroglobulinemia's Patients at First Relapse
Study ID: NCT02371148
Conditions
Interventions
Study Description
Brief Summary: This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia.
Detailed Description: The progression free survival (PFS) expected for lymphoplasmacytic/lymphoplasmocytoid lymphoma/Waldenstrom macroglobulinemia with the same characteristics indicated into the study and treated with standard Rituximab plus chemotherapy may be estimated to be 50% at 18 months. The Investigators would consider a positive result to increase 18 months-PFS rate from 50 to 65%.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
AO Riuniti Papardo Piemonte, Messina, ME, Italy
Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, PZ, Italy
AUSL di Ravenna, Ravenna, RA, Italy
A.O. Bianchi - Melacrino - Morelli, Reggio Calabria, RC, Italy
Nuovo Regina Margherita, Roma, RM, Italy
Uo Oncoematologia, Po "A.Tortora", Pagani, Salerno, Italy
Ospedale S. Giacomo di Castelfranco Veneto, Castelfranco Veneto, Treviso, Italy
A.O. SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona, Ancona, , Italy
Centro di riferimento Oncologico - Oncologia Medica A, Aviano (PN), , Italy
A.O. Ospedale Degli Infermi, Biella, , Italy
Ospedale Businco, Divisione di Ematologia, Cagliari, , Italy
Area Vasta Romagna e IRST, Meldola (FC), , Italy
Irccs Ospedale Maggiore Policlinico Di Milano, Milano, , Italy
A.O. Universitaria Policlinico Di Modena, Modena, , Italy
Ospedale Maggiore Della Carita' - Scdu Ematologia, Novara, , Italy
Ospedale San Martino, Asl Oristano- Ematologia, Oristano, , Italy
Ematologia Policlinico San Matteo, Pavia, , Italy
Ausl Di Piacenza, Piacenza, , Italy
Ausl Di Rimini, Rimini, , Italy
Ematologia 1 - A.O. Citta' Della Salute E Della Scienza Di Torino, Torino, , Italy
Città della Salute e della Scienza SC Ematologia, Torino, , Italy
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI, Varese, , Italy
Contact Details
Name: Lorella Orsucci, MD
Affiliation: SC EMATOLOGIA - AO CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
Role: PRINCIPAL_INVESTIGATOR
Name: Giulia Benevolo, MD
Affiliation: SC EMATOLOGIA - AO CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
Role: PRINCIPAL_INVESTIGATOR
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