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

November 15, 2013 updated by: Fondazione Italiana Linfomi ONLUS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Ospedale Civile SS. Antonio E Biagio DI Alessandria
      • Bolzano, Italy, 39100
        • Recruiting
        • ASP di Bolzano - Comprensorio sanitario di Bolzano
        • Principal Investigator:
          • Atto Billio, MD
      • Brescia, Italy, 25123
        • Recruiting
        • Pres.Ospedal.Spedali Civili Brescia
      • Brindisi, Italy, 72100
        • Recruiting
        • Stabilimento "Perrino"
        • Principal Investigator:
          • Giovanni Quarta, MD
      • Cagliari, Italy, 09123
        • Recruiting
        • Ospedale Armando Businco -
      • Catania, Italy, 95124
        • Recruiting
        • A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania
      • Catania, Italy, 95124
        • Recruiting
        • Nuovo Ospedale Garibaldi - Nesima
        • Principal Investigator:
          • Patrizia Guglielmo, MD
      • Como, Italy, 22100
        • Recruiting
        • Osp.Generale Di Zona Valduce
        • Principal Investigator:
          • Erika Ravelli, MD
      • Cosenza, Italy, 87100
        • Recruiting
        • Presidio Ospedaliero Annunziata
      • Genova, Italy, 16132
        • Recruiting
        • A.O. Universitaria S. Martino Di Genova
      • Matera, Italy, 75100
        • Recruiting
        • Presidio Ospedaliero Matera
      • Messina, Italy, 98125
        • Recruiting
        • A.O. Universitaria Policlinico Martino Di Messina
        • Principal Investigator:
          • Caterina Musolino, MD
      • Messina, Italy, 98158
        • Recruiting
        • Azienda Ospedaliera Papardo
      • Milano, Italy, 20133
        • Recruiting
        • Irccs Istituto Nazionale Dei Tumori (Int)
        • Principal Investigator:
          • Alessandro Gianni, Prof.
      • Milano, Italy, 20153
        • Recruiting
        • Ospedale S. Carlo Borromeo
        • Principal Investigator:
          • Lucilla Tedeschi, MD
      • Milano, Italy, 20162
        • Recruiting
        • Ospedale Ca' Granda-Niguarda
      • Modena, Italy, 41124
        • Recruiting
        • A.O. Universitaria Policlinico Di Modena
      • Monza, Italy, 20900
        • Recruiting
        • Azienda Ospedaliera S. Gerardo di Monza
        • Principal Investigator:
          • Enrico Maria Pogliani, Prof.
      • Padova, Italy, 35128
        • Recruiting
        • IRCCS Istituto Oncologico Veneto (IOV)
      • Palermo, Italy, 90127
        • Recruiting
        • A.O. Universitaria Policlinico Giaccone Di Palermo
      • Palermo, Italy, 90146
        • Recruiting
        • A.O. "V. Cervello"
      • Palermo, Italy, 90146
        • Recruiting
        • Casa Di Cura La Maddalena Di Palermo
      • Parma, Italy, 43126
        • Recruiting
        • A.O. Universitaria Di Parma
      • Pescara, Italy, 65100
        • Recruiting
        • Ospedale Civile Spirito Santo
        • Principal Investigator:
          • Francesco Angrilli, MD
      • Piacenza, Italy, 29121
        • Recruiting
        • AUSL di Piacenza
      • Pisa, Italy, 56126
        • Recruiting
        • A.O. Universitaria Pisana
      • Ravenna, Italy, 48121
        • Recruiting
        • Ospedale S. Maria Delle Croci Di Di Ravenna
        • Principal Investigator:
          • Barbara Castagnari, MD
      • Reggio Emilia, Italy, 42100
        • Recruiting
        • Ospedale di S. Maria Nuova
      • Rimini, Italy, 47900
        • Recruiting
        • Ospedale di Rimini
        • Principal Investigator:
          • Annalia Molinari, MD
      • Roma, Italy, 00144
        • Recruiting
        • IRCCS Istituto Regina Elena (IFO)
        • Principal Investigator:
          • Maria Concetta Petti, Proff.
      • Roma, Italy, 00144
        • Recruiting
        • Ospedale S. Eugenio
        • Principal Investigator:
          • Alessio Pio Perrotti, MD
      • Roma, Italy, 00184
        • Recruiting
        • Azienda Osp. S.Giovanni/Addolorata Roma
        • Principal Investigator:
          • Luciana Annino, Proff.
      • Salerno, Italy, 84100
        • Recruiting
        • A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar
      • Sassari, Italy, 07100
        • Recruiting
        • A.O. Universitaria Policlinico Di Sassari
        • Principal Investigator:
          • Maurizio Longinotti, Prof.
      • Siena, Italy, 53100
        • Recruiting
        • A.O. Universitaria Senese
      • Taranto, Italy, 74100
        • Recruiting
        • Stabilimento SS. Annunziata
        • Principal Investigator:
          • Emilio Iannitto, MD
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera "S. Maria"
      • Torino, Italy, 10126
        • Recruiting
        • Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
      • Torino, Italy, 10126
        • Recruiting
        • Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO
        • Principal Investigator:
          • Annalisa Chiappella, MD
      • Varese, Italy, 21100
        • Recruiting
        • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
      • Varese, Italy, 21100
        • Recruiting
        • Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
    • Bari
      • Acquaviva Delle Fonti, Bari, Italy, 70124
        • Recruiting
        • Ente Eccl.Osp.Gen.Reg.'Miulli'
        • Principal Investigator:
          • Giuseppe Polimeno, MD
    • Barletta
      • Trani, Barletta, Italy, 76125
        • Recruiting
        • Ospedale S. Nicola Pellegrino Di Trani
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Recruiting
        • IRCCS Ospedale Casa Sollievo della Sofferenza
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
        • Recruiting
        • IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Macerata
      • Civitanova Marche, Macerata, Italy, 62012
        • Recruiting
        • Ospedale Generale di Zona
        • Principal Investigator:
          • Riccardo Centurioni, MD
    • Modena
      • Sassuolo, Modena, Italy, 41049
        • Recruiting
        • Nuovo Ospedale Di Sassuolo S.P.A.
        • Principal Investigator:
          • Giovanni Partesotti, MD
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • Irccs Centro Di Riferimento Oncologico (CRO)
    • Potenza
      • Rionero in Vulture, Potenza, Italy, 85128
        • Recruiting
        • Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
    • Reggio Calabria
      • Reggio Di Calabria, Reggio Calabria, Italy, 89124
        • Recruiting
        • Ospedale Bianchi - Melacrino - Morelli
    • Salerno
      • Nocera Inferiore, Salerno, Italy, 84014
        • Recruiting
        • P.O. Umberto I
    • Torino
      • Ivrea, Torino, Italy, 10015
        • Recruiting
        • Ospedale Civile di Ivrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the activity of R-B combination in terms of complete response rate (CRR).
Time Frame: 4 years
4 years
To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate progression free survival (PFS)
Time Frame: 4 years
4 years
To evaluate overall survival (OS)
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Michele Spina, MD, IRCCS CENTRO DI RIFERIMENTO ONCOLOGICO (CRO) - AVIANO (PN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

February 1, 2016

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_R-BENDA FRAIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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