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The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bendamustine | Experimental | Bendamustine is a novel chemotherapeutic agent, a hybrid of a purine analogue and an alkylator. It shows only partial in vitro cross-resistance with other alkylating agents and it is clinically well tolerated. In fact it has shown to be active in vitro against cell lines which are resistant to other alkylating agents. Preclinical data demonstrate that bendamustine acts in two distinct ways to kill cancer cells: it damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway known as mitotic catastrophe (a disruption of normal cell division). This dual-effect may be attributable to its unique chemical structure.Bendamustine has demonstrated clinical activity in patients with chronic lymphocytic leukaemia, patients with relapsed indolent NHL, mantle cell lymphoma, multiple myeloma and several solid tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine+Rituximab | Drug | Patients will receive :
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the activity of R-B combination in terms of complete response rate (CRR). | 4 years | |
| To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate progression free survival (PFS) | 4 years | |
| To evaluate overall survival (OS) | 4 years |
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Inclusion Criteria:
Histologically proven CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
Age > 70 years
No previous treatment
FRAIL patients defined as follows (see Appendices B-E) Age > 80 years with UNFIT profile, i.e.
or Age < 80 years with
ADL < 4 residual functions, or
IADL < 5 residual functions, or
CIRS : 1 co-morbidity of grade 3-4, or > 8 co-morbidities of grade 2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Calabrese, Dr | Contact | +39 0131 206129 | segreteria@filinf.it | |
| Sonia Perticone, Dr | Contact | +39 0131 206129 | segreteria@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Michele Spina, MD | IRCCS CENTRO DI RIFERIMENTO ONCOLOGICO (CRO) - AVIANO (PN) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile Ss. Antonio E Biagio Di Alessandria | Recruiting | Alessandria | Alessandria | 15121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29748444 | Derived | Storti S, Spina M, Pesce EA, Salvi F, Merli M, Ruffini A, Cabras G, Chiappella A, Angelucci E, Fabbri A, Liberati AM, Tani M, Musuraca G, Molinari A, Petrilli MP, Palladino C, Ciancia R, Ferrario A, Gasbarrino C, Monaco F, Fraticelli V, De Vellis A, Merli F, Luminari S. Rituximab plus bendamustine as front-line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-Hodgkin lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi. Haematologica. 2018 Aug;103(8):1345-1350. doi: 10.3324/haematol.2017.186569. Epub 2018 May 10. |
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| Ente Eccl.Osp.Gen.Reg.'Miulli' | Recruiting | Acquaviva delle Fonti | Bari | 70124 | Italy |
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| Ospedale S. Nicola Pellegrino Di Trani | Recruiting | Trani | Barletta | 76125 | Italy |
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| Asp Di Bolzano - Comprensorio Sanitario Di Bolzano | Recruiting | Bolzano | Bolzano | 39100 | Italy |
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| Pres.Ospedal.Spedali Civili Brescia | Recruiting | Brescia | Brescia | 25123 | Italy |
|
| Stabilimento "Perrino" | Recruiting | Brindisi | Brindisi | 72100 | Italy |
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| Ospedale Armando Businco - | Recruiting | Cagliari | Cagliari | 09123 | Italy |
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| A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania | Recruiting | Catania | Catania | 95124 | Italy |
|
| Nuovo Ospedale Garibaldi - Nesima | Recruiting | Catania | Catania | 95124 | Italy |
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| Osp.Generale Di Zona Valduce | Recruiting | Como | Como | 22100 | Italy |
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| Presidio Ospedaliero Annunziata | Recruiting | Cosenza | Cosenza | 87100 | Italy |
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| Irccs Ospedale Casa Sollievo Della Sofferenza | Recruiting | San Giovanni Rotondo | Foggia | 71013 | Italy |
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| Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori | Recruiting | Meldola | Forlì-Cesena | 47014 | Italy |
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| A.O. Universitaria S. Martino Di Genova | Recruiting | Genova | Genova | 16132 | Italy |
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| Ospedale Generale Di Zona | Recruiting | Civitanova Marche | Macerata | 62012 | Italy |
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| Presidio Ospedaliero Matera | Recruiting | Matera | Matera | 75100 | Italy |
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| A.O. Universitaria Policlinico Martino Di Messina | Recruiting | Messina | Messina | 98125 | Italy |
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| Azienda Ospedaliera Papardo | Recruiting | Messina | Messina | 98158 | Italy |
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| Irccs Istituto Nazionale Dei Tumori (Int) | Recruiting | Milan | Milano | 20133 | Italy |
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| Ospedale S. Carlo Borromeo | Recruiting | Milan | Milano | 20153 | Italy |
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| Ospedale Ca' Granda-Niguarda | Recruiting | Milan | Milano | 20162 | Italy |
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| A.O. Universitaria Policlinico Di Modena | Recruiting | Modena | Modena | 41124 | Italy |
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| Nuovo Ospedale Di Sassuolo S.P.A. | Recruiting | Sassuolo | Modena | 41049 | Italy |
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| Azienda Ospedaliera S. Gerardo Di Monza | Recruiting | Monza | Monza | 20900 | Italy |
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| Irccs Istituto Oncologico Veneto (Iov) | Recruiting | Padova | Padova | 35128 | Italy |
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| A.O. Universitaria Policlinico Giaccone Di Palermo | Recruiting | Palermo | Palermo | 90127 | Italy |
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| A.O. "V. Cervello" | Recruiting | Palermo | Palermo | 90146 | Italy |
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| Casa Di Cura La Maddalena Di Palermo | Recruiting | Palermo | Palermo | 90146 | Italy |
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| A.O. Universitaria Di Parma | Recruiting | Parma | Parma | 43126 | Italy |
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| Ospedale Civile Spirito Santo | Recruiting | Pescara | Pescara | 65100 | Italy |
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| Ausl Di Piacenza | Recruiting | Piacenza | Piacenza | 29121 | Italy |
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| A.O. Universitaria Pisana | Recruiting | Pisa | Pisa | 56126 | Italy |
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| Irccs Centro Di Riferimento Oncologico (Cro) | Recruiting | Aviano | Pordenone | 33081 | Italy |
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| Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob) | Recruiting | Rionero in Vulture | Potenza | 85128 | Italy |
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| Ospedale S. Maria Delle Croci Di Di Ravenna | Recruiting | Ravenna | Ravenna | 48121 | Italy |
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| Ospedale Bianchi - Melacrino - Morelli | Recruiting | Reggio Calabria | Reggio Calabria | 89124 | Italy |
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| Ospedale Di S. Maria Nuova | Recruiting | Reggio Emilia | Reggio Emilia | 42100 | Italy |
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| Ospedale Di Rimini | Recruiting | Rimini | Rimini | 47900 | Italy |
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| Irccs Istituto Regina Elena (Ifo) | Recruiting | Roma | Roma | 00144 | Italy |
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| Ospedale S. Eugenio | Recruiting | Roma | Roma | 00144 | Italy |
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| Azienda Osp. S.Giovanni/Addolorata Roma | Recruiting | Roma | Roma | 00184 | Italy |
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| P.O. Umberto I | Recruiting | Nocera Inferiore | Salerno | 84014 | Italy |
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| A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar | Recruiting | Salerno | Salerno | 84100 | Italy |
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| A.O. Universitaria Policlinico Di Sassari | Recruiting | Sassari | Sassari | 07100 | Italy |
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| A.O. Universitaria Senese | Recruiting | Siena | Siena | 53100 | Italy |
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| Stabilimento Ss. Annunziata | Recruiting | Taranto | Taranto | 74100 | Italy |
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| Azienda Ospedaliera "S. Maria" | Recruiting | Terni | Terni | 05100 | Italy |
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| Ospedale Civile Di Ivrea | Recruiting | Ivrea | Torino | 10015 | Italy |
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| Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO | Recruiting | Torino | Torino | 10126 | Italy |
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| Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO | Recruiting | Torino | Torino | 10126 | Italy |
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| Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI | Recruiting | Varese | Varese | 21100 | Italy |
|
| Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI | Recruiting | Varese | Varese | 21100 | Italy |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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