Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL
NCT ID: NCT01990144
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
49 participants
INTERVENTIONAL
2011-11-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bendamustine
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.
Bendamustine+Rituximab
Patients will receive :
* Rituximab 375 mg/m2 intravenously on day 1\*
* Bendamustine 90 mg/m2 intravenously on days 2 and 3\*\* Treatment will be administered on a 28-day cycle basis.
* Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1.
* After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice.
Interventions
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Bendamustine+Rituximab
Patients will receive :
* Rituximab 375 mg/m2 intravenously on day 1\*
* Bendamustine 90 mg/m2 intravenously on days 2 and 3\*\* Treatment will be administered on a 28-day cycle basis.
* Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1.
* After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice.
Eligibility Criteria
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Inclusion Criteria
* Age \> 70 years
* No previous treatment
* FRAIL patients defined as follows (see Appendices B-E) Age \> 80 years with UNFIT profile, i.e.
* ADL \> 5 residual functions
* IADL \> 6 residual functions
* CIRS 5-8 co-morbidities of grade 2
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
* Life expectancy \> 6 months
* Written informed consent
* Accessibility of patient for treatment and follow up
Exclusion Criteria
* Previous exposure to cytotoxic agents
* Suspect or clinical evidence of CNS involvement by lymphoma
* HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine
* AST /ALT \> twice upper the normal range; bilirubin \> twice upper the normal range; serum creatinine \> 2.5 mg /dl
* Evidence of any severe active acute or chronic infection
* Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
* Senile dementia
* Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
70 Years
ALL
Yes
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Michele Spina, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS CENTRO DI RIFERIMENTO ONCOLOGICO (CRO) - AVIANO (PN)
Locations
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Ospedale Civile Ss. Antonio E Biagio Di Alessandria
Alessandria, Alessandria, Italy
Ente Eccl.Osp.Gen.Reg.'Miulli'
Acquaviva delle Fonti, Bari, Italy
Ospedale S. Nicola Pellegrino Di Trani
Trani, Barletta, Italy
Asp Di Bolzano - Comprensorio Sanitario Di Bolzano
Bolzano, Bolzano, Italy
Pres.Ospedal.Spedali Civili Brescia
Brescia, Brescia, Italy
Stabilimento "Perrino"
Brindisi, Brindisi, Italy
Ospedale Armando Businco -
Cagliari, Cagliari, Italy
A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania
Catania, Catania, Italy
Nuovo Ospedale Garibaldi - Nesima
Catania, Catania, Italy
Osp.Generale Di Zona Valduce
Como, Como, Italy
Presidio Ospedaliero Annunziata
Cosenza, Cosenza, Italy
Irccs Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, Forlì-Cesena, Italy
A.O. Universitaria S. Martino Di Genova
Genova, Genova, Italy
Ospedale Generale Di Zona
Civitanova Marche, Macerata, Italy
Presidio Ospedaliero Matera
Matera, Matera, Italy
A.O. Universitaria Policlinico Martino Di Messina
Messina, Messina, Italy
Azienda Ospedaliera Papardo
Messina, Messina, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Milano, Italy
Ospedale S. Carlo Borromeo
Milan, Milano, Italy
Ospedale Ca' Granda-Niguarda
Milan, Milano, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Modena, Italy
Nuovo Ospedale Di Sassuolo S.P.A.
Sassuolo, Modena, Italy
Azienda Ospedaliera S. Gerardo Di Monza
Monza, Monza, Italy
Irccs Istituto Oncologico Veneto (Iov)
Padua, Padova, Italy
A.O. Universitaria Policlinico Giaccone Di Palermo
Palermo, Palermo, Italy
A.O. "V. Cervello"
Palermo, Palermo, Italy
Casa Di Cura La Maddalena Di Palermo
Palermo, Palermo, Italy
A.O. Universitaria Di Parma
Parma, Parma, Italy
Ospedale Civile Spirito Santo
Pescara, Pescara, Italy
Ausl Di Piacenza
Piacenza, Piacenza, Italy
A.O. Universitaria Pisana
Pisa, Pisa, Italy
Irccs Centro Di Riferimento Oncologico (Cro)
Aviano, Pordenone, Italy
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Rionero in Vulture, Potenza, Italy
Ospedale S. Maria Delle Croci Di Di Ravenna
Ravenna, Ravenna, Italy
Ospedale Bianchi - Melacrino - Morelli
Reggio Calabria, Reggio Calabria, Italy
Ospedale Di S. Maria Nuova
Reggio Emilia, Reggio Emilia, Italy
Ospedale Di Rimini
Rimini, Rimini, Italy
Irccs Istituto Regina Elena (Ifo)
Roma, Roma, Italy
Ospedale S. Eugenio
Roma, Roma, Italy
Azienda Osp. S.Giovanni/Addolorata Roma
Roma, Roma, Italy
P.O. Umberto I
Nocera Inferiore, Salerno, Italy
A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar
Salerno, Salerno, Italy
A.O. Universitaria Policlinico Di Sassari
Sassari, Sassari, Italy
A.O. Universitaria Senese
Siena, Siena, Italy
Stabilimento Ss. Annunziata
Taranto, Taranto, Italy
Azienda Ospedaliera "S. Maria"
Terni, Terni, Italy
Ospedale Civile Di Ivrea
Ivrea, Torino, Italy
Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
Torino, Torino, Italy
Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
Torino, Torino, Italy
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Varese, Varese, Italy
Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Varese, Varese, Italy
Countries
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Central Contacts
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References
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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.
Other Identifiers
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FIL_R-BENDA FRAIL
Identifier Type: -
Identifier Source: org_study_id