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Diffuse Large B-cell LymphomaPhase 2NCT01990144

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

A Phase 2 study testing Bendamustine+Rituximab in people with Diffuse Large B-cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 52 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Bendamustine+Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
52 sitesItaly
Study dates
Nov 2011to Feb 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

52 sites in 1 country.

Marco Calabrese, Dr contact

+39 0131 206129

segreteria@filinf.it

Sonia Perticone, Dr contact

+39 0131 206129

segreteria@filinf.it

52 sites in 1 country

Italy52 sites, 52 recruiting

  • Ente Eccl.Osp.Gen.Reg.'Miulli'

    Acquaviva delle Fonti, Bari, 70124

    Giuseppe Polimeno, MD

    Recruiting

  • Ospedale Civile Ss. Antonio E Biagio Di Alessandria

    Alessandria, Alessandria, 15121

    Flavia Salvi, MD

    Recruiting

  • Irccs Centro Di Riferimento Oncologico (Cro)

    Aviano, Pordenone, 33081

    Michele Spina, MD

    Recruiting

  • Asp Di Bolzano - Comprensorio Sanitario Di Bolzano

    Bolzano, Bolzano, 39100

    Atto Billio, MD

    Recruiting

  • Pres.Ospedal.Spedali Civili Brescia

    Brescia, Brescia, 25123

    Alessandra Tucci, MD

    Recruiting

  • Stabilimento "Perrino"

    Brindisi, Brindisi, 72100

    Giovanni Quarta, MD

    Recruiting

  • Ospedale Armando Businco -

    Cagliari, Cagliari, 09123

    Emanuele Angelucci, MD

    Recruiting

  • A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania

    Catania, Catania, 95124

    Francesco Di Raimondo, MD

    Recruiting

  • Nuovo Ospedale Garibaldi - Nesima

    Catania, Catania, 95124

    Patrizia Guglielmo, MD

    Recruiting

  • Ospedale Generale Di Zona

    Civitanova Marche, Macerata, 62012

    Riccardo Centurioni, MD

    Recruiting

  • Osp.Generale Di Zona Valduce

    Como, Como, 22100

    Erika Ravelli, MD

    Recruiting

  • Presidio Ospedaliero Annunziata

    Cosenza, Cosenza, 87100

    Fortunato Morabito, MD

    Recruiting

  • A.O. Universitaria S. Martino Di Genova

    Genova, Genova, 16132

    Marco Gobbi, MD

    Recruiting

  • Ospedale Civile Di Ivrea

    Ivrea, Torino, 10015

    Roberto Freilone, MD

    Recruiting

  • Presidio Ospedaliero Matera

    Matera, Matera, 75100

    Alberto Fragasso, MD

    Recruiting

  • Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola, Forlì-Cesena, 47014

    Gerardo Musuraca, MD

    Recruiting

  • A.O. Universitaria Policlinico Martino Di Messina

    Messina, Messina, 98125

    Caterina Musolino, MD

    Recruiting

  • Azienda Ospedaliera Papardo

    Messina, Messina, 98158

    Maura Brugiatelli, MD

    Recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Milano, 20133

    Alessandro Gianni, Prof.

    Recruiting

  • Ospedale S. Carlo Borromeo

    Milan, Milano, 20153

    Lucilla Tedeschi, MD

    Recruiting

  • Ospedale Ca' Granda-Niguarda

    Milan, Milano, 20162

    Chiara Rusconi, MD

    Recruiting

  • A.O. Universitaria Policlinico Di Modena

    Modena, Modena, 41124

    Stefano Luminari, MD

    Recruiting

  • Azienda Ospedaliera S. Gerardo Di Monza

    Monza, Monza, 20900

    Enrico Maria Pogliani, Prof.

    Recruiting

  • P.O. Umberto I

    Nocera Inferiore, Salerno, 84014

    Alfonso Maria D'Arco, MD

    Recruiting

  • Irccs Istituto Oncologico Veneto (Iov)

    Padova, Padova, 35128

    Dario Marino, MD

    Recruiting

  • A.O. Universitaria Policlinico Giaccone Di Palermo

    Palermo, Palermo, 90127

    Salvatrice Mancuso, MD

    Recruiting

  • A.O. "V. Cervello"

    Palermo, Palermo, 90146

    Caterina Patti, MD

    Recruiting

  • Casa Di Cura La Maddalena Di Palermo

    Palermo, Palermo, 90146

    Maurizio Musso, MD

    Recruiting

  • A.O. Universitaria Di Parma

    Parma, Parma, 43126

    Francesca Re, MD

    Recruiting

  • Ospedale Civile Spirito Santo

    Pescara, Pescara, 65100

    Francesco Angrilli, MD

    Recruiting

  • Ausl Di Piacenza

    Piacenza, Piacenza, 29121

    Annalisa Arcari, MD

    Recruiting

  • A.O. Universitaria Pisana

    Pisa, Pisa, 56126

    Mario Petrini, Prof.

    Recruiting

  • Ospedale S. Maria Delle Croci Di Di Ravenna

    Ravenna, Ravenna, 48121

    Barbara Castagnari, MD

    Recruiting

  • Ospedale Bianchi - Melacrino - Morelli

    Reggio Calabria, Reggio Calabria, 89124

    Caterina Stelitano, MD

    Recruiting

  • Ospedale Di S. Maria Nuova

    Reggio Emilia, Reggio Emilia, 42100

    Francesco Merli, MD

    Recruiting

  • Ospedale Di Rimini

    Rimini, Rimini, 47900

    Annalia Molinari, MD

    Recruiting

  • Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)

    Rionero in Vulture, Potenza, 85128

    Pellegrino Musto, MD

    Recruiting

  • Irccs Istituto Regina Elena (Ifo)

    Roma, Roma, 00144

    Maria Concetta Petti, Proff.

    Recruiting

  • Ospedale S. Eugenio

    Roma, Roma, 00144

    Alessio Pio Perrotti, MD

    Recruiting

  • Azienda Osp. S.Giovanni/Addolorata Roma

    Roma, Roma, 00184

    Luciana Annino, Proff.

    Recruiting

  • A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar

    Salerno, Salerno, 84100

    Carmine Selleri, MD

    Recruiting

  • Irccs Ospedale Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

    Nicola Cascavilla, MD

    Recruiting

  • A.O. Universitaria Policlinico Di Sassari

    Sassari, Sassari, 07100

    Maurizio Longinotti, Prof.

    Recruiting

  • Nuovo Ospedale Di Sassuolo S.P.A.

    Sassuolo, Modena, 41049

    Giovanni Partesotti, MD

    Recruiting

  • A.O. Universitaria Senese

    Siena, Siena, 53100

    Alberto Fabbri, MD

    Recruiting

  • Stabilimento Ss. Annunziata

    Taranto, Taranto, 74100

    Emilio Iannitto, MD

    Recruiting

  • Azienda Ospedaliera "S. Maria"

    Terni, Terni, 05100

    Anna Maria Liberati, MD

    Recruiting

  • Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO

    Torino, Torino, 10126

    Marco Ladetto, MD

    Recruiting

  • Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO

    Torino, Torino, 10126

    Annalisa Chiappella, MD

    Recruiting

  • Ospedale S. Nicola Pellegrino Di Trani

    Trani, Barletta, 76125

    Giuseppe Tarantini, MD

    Recruiting

  • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

    Varese, Varese, 21100

    Francesco Passamonti, Proff.

    Recruiting

  • Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

    Varese, Varese, 21100

    Graziella Pinotti, MD

    Recruiting

Other trials in Italy

About this study

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)

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.

Being tested
Bendamustine+Rituximab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bendamustine+RituximabDrug

    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.
Study groups in NCT01990144
Study groupRoleWhat they receive
BendamustineExperimentalBendamustine 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.
Receives: Drug: Bendamustine+Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the activity of R-B combination in terms of complete response rate (CRR).

    Measured: 4 years

  2. To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.

    Measured: 4 years

Secondary outcomes (2)

  1. To evaluate progression free survival (PFS)

    Measured: 4 years

  2. To evaluate overall survival (OS)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study startNov 2011
  3. Primary completionFeb 2014 (estimated)
  4. Study completionFeb 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01990144
Sponsor's protocol ID
FIL_R-BENDA FRAIL
Status last verified
Nov 2013
First submitted
15 Nov 2013
Last updated
21 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29748444

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine+Rituximab in people with Diffuse Large B-cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 52 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marco Calabrese, Dr (+39 0131 206129, segreteria@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the activity of R-B combination in terms of complete response rate (CRR). (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01990144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.

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