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Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Bendamustine+Rituximab
Sponsored by
Fondazione Italiana Linfomi - ETS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ente Eccl.Osp.Gen.Reg.'Miulli'Recruiting
  • Ospedale S. Nicola Pellegrino Di TraniRecruiting
  • Irccs Ospedale Casa Sollievo Della SofferenzaRecruiting
  • Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei TumoriRecruiting
  • Ospedale Generale Di ZonaRecruiting
  • Nuovo Ospedale Di Sassuolo S.P.A.Recruiting
  • Irccs Centro Di Riferimento Oncologico (Cro)Recruiting
  • Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)Recruiting
  • Ospedale Bianchi - Melacrino - MorelliRecruiting
  • P.O. Umberto IRecruiting
  • Ospedale Civile Di IvreaRecruiting
  • Ospedale Civile Ss. Antonio E Biagio Di AlessandriaRecruiting
  • Asp Di Bolzano - Comprensorio Sanitario Di BolzanoRecruiting
  • Pres.Ospedal.Spedali Civili BresciaRecruiting
  • Stabilimento "Perrino"Recruiting
  • Ospedale Armando Businco -Recruiting
  • A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di CataniaRecruiting
  • Nuovo Ospedale Garibaldi - NesimaRecruiting
  • Osp.Generale Di Zona ValduceRecruiting
  • Presidio Ospedaliero AnnunziataRecruiting
  • A.O. Universitaria S. Martino Di GenovaRecruiting
  • Presidio Ospedaliero MateraRecruiting
  • A.O. Universitaria Policlinico Martino Di MessinaRecruiting
  • Azienda Ospedaliera PapardoRecruiting
  • Irccs Istituto Nazionale Dei Tumori (Int)Recruiting
  • Ospedale S. Carlo BorromeoRecruiting
  • Ospedale Ca' Granda-NiguardaRecruiting
  • A.O. Universitaria Policlinico Di ModenaRecruiting
  • Azienda Ospedaliera S. Gerardo Di MonzaRecruiting
  • Irccs Istituto Oncologico Veneto (Iov)Recruiting
  • A.O. Universitaria Policlinico Giaccone Di PalermoRecruiting
  • A.O. "V. Cervello"Recruiting
  • Casa Di Cura La Maddalena Di PalermoRecruiting
  • A.O. Universitaria Di ParmaRecruiting
  • Ospedale Civile Spirito SantoRecruiting
  • Ausl Di PiacenzaRecruiting
  • A.O. Universitaria PisanaRecruiting
  • Ospedale S. Maria Delle Croci Di Di RavennaRecruiting
  • Ospedale Di S. Maria NuovaRecruiting
  • Ospedale Di RiminiRecruiting
  • Irccs Istituto Regina Elena (Ifo)Recruiting
  • Ospedale S. EugenioRecruiting
  • Azienda Osp. S.Giovanni/Addolorata RomaRecruiting
  • A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'ArRecruiting
  • A.O. Universitaria Policlinico Di SassariRecruiting
  • A.O. Universitaria SeneseRecruiting
  • Stabilimento Ss. AnnunziataRecruiting
  • Azienda Ospedaliera "S. Maria"Recruiting
  • Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINORecruiting
  • Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINORecruiting
  • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHIRecruiting
  • Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bendamustine

Arm Description

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.

Outcomes

Primary Outcome Measures

To evaluate the activity of R-B combination in terms of complete response rate (CRR).
To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.

Secondary Outcome Measures

To evaluate progression free survival (PFS)
To evaluate overall survival (OS)

Full Information

First Posted
November 15, 2013
Last Updated
November 15, 2013
Sponsor
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT01990144
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Italiana Linfomi - ETS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bendamustine+Rituximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the activity of R-B combination in terms of complete response rate (CRR).
Time Frame
4 years
Title
To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
To evaluate progression free survival (PFS)
Time Frame
4 years
Title
To evaluate overall survival (OS)
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Calabrese, Dr
Phone
+39 0131 206129
Email
segreteria@filinf.it
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Perticone, Dr
Phone
+39 0131 206129
Email
segreteria@filinf.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Spina, MD
Organizational Affiliation
IRCCS CENTRO DI RIFERIMENTO ONCOLOGICO (CRO) - AVIANO (PN)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ente Eccl.Osp.Gen.Reg.'Miulli'
City
Acquaviva Delle Fonti
State/Province
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Polimeno, MD
Facility Name
Ospedale S. Nicola Pellegrino Di Trani
City
Trani
State/Province
Barletta
ZIP/Postal Code
76125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Tarantini, MD
Facility Name
Irccs Ospedale Casa Sollievo Della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Cascavilla, MD
Facility Name
Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
City
Meldola
State/Province
Forlì-Cesena
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerardo Musuraca, MD
Facility Name
Ospedale Generale Di Zona
City
Civitanova Marche
State/Province
Macerata
ZIP/Postal Code
62012
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Centurioni, MD
Facility Name
Nuovo Ospedale Di Sassuolo S.P.A.
City
Sassuolo
State/Province
Modena
ZIP/Postal Code
41049
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Partesotti, MD
Facility Name
Irccs Centro Di Riferimento Oncologico (Cro)
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Spina, MD
Facility Name
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
City
Rionero in Vulture
State/Province
Potenza
ZIP/Postal Code
85128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pellegrino Musto, MD
Facility Name
Ospedale Bianchi - Melacrino - Morelli
City
Reggio Di Calabria
State/Province
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Stelitano, MD
Facility Name
P.O. Umberto I
City
Nocera Inferiore
State/Province
Salerno
ZIP/Postal Code
84014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Maria D'Arco, MD
Facility Name
Ospedale Civile Di Ivrea
City
Ivrea
State/Province
Torino
ZIP/Postal Code
10015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Freilone, MD
Facility Name
Ospedale Civile Ss. Antonio E Biagio Di Alessandria
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Salvi, MD
Facility Name
Asp Di Bolzano - Comprensorio Sanitario Di Bolzano
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atto Billio, MD
Facility Name
Pres.Ospedal.Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Tucci, MD
Facility Name
Stabilimento "Perrino"
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Quarta, MD
Facility Name
Ospedale Armando Businco -
City
Cagliari
ZIP/Postal Code
09123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuele Angelucci, MD
Facility Name
A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Di Raimondo, MD
Facility Name
Nuovo Ospedale Garibaldi - Nesima
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Guglielmo, MD
Facility Name
Osp.Generale Di Zona Valduce
City
Como
ZIP/Postal Code
22100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Ravelli, MD
Facility Name
Presidio Ospedaliero Annunziata
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fortunato Morabito, MD
Facility Name
A.O. Universitaria S. Martino Di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Gobbi, MD
Facility Name
Presidio Ospedaliero Matera
City
Matera
ZIP/Postal Code
75100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Fragasso, MD
Facility Name
A.O. Universitaria Policlinico Martino Di Messina
City
Messina
ZIP/Postal Code
98125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Musolino, MD
Facility Name
Azienda Ospedaliera Papardo
City
Messina
ZIP/Postal Code
98158
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Brugiatelli, MD
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Gianni, Prof.
Facility Name
Ospedale S. Carlo Borromeo
City
Milano
ZIP/Postal Code
20153
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucilla Tedeschi, MD
Facility Name
Ospedale Ca' Granda-Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Rusconi, MD
Facility Name
A.O. Universitaria Policlinico Di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Luminari, MD
Facility Name
Azienda Ospedaliera S. Gerardo Di Monza
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Maria Pogliani, Prof.
Facility Name
Irccs Istituto Oncologico Veneto (Iov)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Marino, MD
Facility Name
A.O. Universitaria Policlinico Giaccone Di Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatrice Mancuso, MD
Facility Name
A.O. "V. Cervello"
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caterina Patti, MD
Facility Name
Casa Di Cura La Maddalena Di Palermo
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Musso, MD
Facility Name
A.O. Universitaria Di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Re, MD
Facility Name
Ospedale Civile Spirito Santo
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Angrilli, MD
Facility Name
Ausl Di Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa Arcari, MD
Facility Name
A.O. Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Petrini, Prof.
Facility Name
Ospedale S. Maria Delle Croci Di Di Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Castagnari, MD
Facility Name
Ospedale Di S. Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Merli, MD
Facility Name
Ospedale Di Rimini
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalia Molinari, MD
Facility Name
Irccs Istituto Regina Elena (Ifo)
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Concetta Petti, Proff.
Facility Name
Ospedale S. Eugenio
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessio Pio Perrotti, MD
Facility Name
Azienda Osp. S.Giovanni/Addolorata Roma
City
Roma
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Annino, Proff.
Facility Name
A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar
City
Salerno
ZIP/Postal Code
84100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmine Selleri, MD
Facility Name
A.O. Universitaria Policlinico Di Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Longinotti, Prof.
Facility Name
A.O. Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Fabbri, MD
Facility Name
Stabilimento Ss. Annunziata
City
Taranto
ZIP/Postal Code
74100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Iannitto, MD
Facility Name
Azienda Ospedaliera "S. Maria"
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Maria Liberati, MD
Facility Name
Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Ladetto, MD
Facility Name
Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa Chiappella, MD
Facility Name
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Passamonti, Proff.
Facility Name
Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graziella Pinotti, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29748444
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.
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Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

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