Clinical trial NCT01990144: Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL
Official title: Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma: a Phase II Multicenter Study of the Fondazione Italiana Linfomi (FIL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 49
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

  * 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:

* History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
* 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

Primary outcomes:
measure: To evaluate the activity of R-B combination in terms of complete response rate (CRR).
timeFrame: 4 years
measure: To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.
timeFrame: 4 years
Secondary outcomes:
measure: To evaluate progression free survival (PFS)
timeFrame: 4 years
measure: To evaluate overall survival (OS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Acquaviva Delle Fonti
country: Italy
facility: Ente Eccl.Osp.Gen.Reg.'Miulli'
state: Bari
city: Trani
country: Italy
facility: Ospedale S. Nicola Pellegrino Di Trani
state: Barletta
city: San Giovanni Rotondo
country: Italy
facility: Irccs Ospedale Casa Sollievo Della Sofferenza
state: Foggia
city: Meldola
country: Italy
facility: Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
state: Forlì-Cesena
city: Civitanova Marche
country: Italy
facility: Ospedale Generale Di Zona
state: Macerata
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Di Sassuolo S.P.A.
state: Modena
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (Cro)
state: Pordenone
city: Rionero in Vulture
country: Italy
facility: Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
state: Potenza
city: Reggio Di Calabria
country: Italy
facility: Ospedale Bianchi - Melacrino - Morelli
state: Reggio Calabria
city: Nocera Inferiore
country: Italy
facility: P.O. Umberto I
state: Salerno
city: Ivrea
country: Italy
facility: Ospedale Civile Di Ivrea
state: Torino
city: Alessandria
country: Italy
facility: Ospedale Civile Ss. Antonio E Biagio Di Alessandria
city: Bolzano
country: Italy
facility: Asp Di Bolzano - Comprensorio Sanitario Di Bolzano
city: Brescia
country: Italy
facility: Pres.Ospedal.Spedali Civili Brescia
city: Brindisi
country: Italy
facility: Stabilimento "Perrino"
city: Cagliari
country: Italy
facility: Ospedale Armando Businco -
city: Catania
country: Italy
facility: A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania
city: Catania
country: Italy
facility: Nuovo Ospedale Garibaldi - Nesima
city: Como
country: Italy
facility: Osp.Generale Di Zona Valduce
city: Cosenza
country: Italy
facility: Presidio Ospedaliero Annunziata
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova
city: Matera
country: Italy
facility: Presidio Ospedaliero Matera
city: Messina
country: Italy
facility: A.O. Universitaria Policlinico Martino Di Messina
city: Messina
country: Italy
facility: Azienda Ospedaliera Papardo
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
city: Milano
country: Italy
facility: Ospedale S. Carlo Borromeo
city: Milano
country: Italy
facility: Ospedale Ca' Granda-Niguarda
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo Di Monza
city: Padova
country: Italy
facility: Irccs Istituto Oncologico Veneto (Iov)
city: Palermo
country: Italy
facility: A.O. Universitaria Policlinico Giaccone Di Palermo
city: Palermo
country: Italy
facility: A.O. "V. Cervello"
city: Palermo
country: Italy
facility: Casa Di Cura La Maddalena Di Palermo
city: Parma
country: Italy
facility: A.O. Universitaria Di Parma
city: Pescara
country: Italy
facility: Ospedale Civile Spirito Santo
city: Piacenza
country: Italy
facility: Ausl Di Piacenza
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci Di Di Ravenna
city: Reggio Emilia
country: Italy
facility: Ospedale Di S. Maria Nuova
city: Rimini
country: Italy
facility: Ospedale Di Rimini
city: Roma
country: Italy
facility: Irccs Istituto Regina Elena (Ifo)
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Azienda Osp. S.Giovanni/Addolorata Roma
city: Salerno
country: Italy
facility: A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar
city: Sassari
country: Italy
facility: A.O. Universitaria Policlinico Di Sassari
city: Siena
country: Italy
facility: A.O. Universitaria Senese
city: Taranto
country: Italy
facility: Stabilimento Ss. Annunziata
city: Terni
country: Italy
facility: Azienda Ospedaliera "S. Maria"
city: Torino
country: Italy
facility: Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
city: Torino
country: Italy
facility: Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
city: Varese
country: Italy
facility: Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
city: Varese
country: Italy
facility: Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Study officials:
affiliation: IRCCS CENTRO DI RIFERIMENTO ONCOLOGICO (CRO) - AVIANO (PN)
name: Michele Spina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.