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

Phase 2

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Bendamustine+Rituximab

• Registration Number: NCT01990144
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2013-11
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Last Update Submitted: 2013-11-15
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21
• Primary Completion: 2014-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bendamustine	Bendamustine+Rituximab	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate progression free survival (PFS)	4 years
To evaluate overall survival (OS)	4 years

Trial Locations

Locations (52)

Ospedale Generale Di Zona; 🇮🇹 Civitanova Marche, Macerata, Italy

Irccs Centro Di Riferimento Oncologico (Cro); 🇮🇹 Aviano, Pordenone, Italy

A.O. Universitaria S. Martino Di Genova; 🇮🇹 Genova, Italy

Ospedale Ca' Granda-Niguarda; 🇮🇹 Milano, Italy

Ospedale S. Nicola Pellegrino Di Trani; 🇮🇹 Trani, Barletta, Italy

Ospedale S. Eugenio; 🇮🇹 Roma, Italy

A.O. Universitaria Policlinico Martino Di Messina; 🇮🇹 Messina, Italy

Azienda Ospedaliera Papardo; 🇮🇹 Messina, Italy

Irccs Istituto Nazionale Dei Tumori (Int); 🇮🇹 Milano, Italy

Ospedale S. Carlo Borromeo; 🇮🇹 Milano, Italy

Ausl Di Piacenza; 🇮🇹 Piacenza, Italy

Ospedale S. Maria Delle Croci Di Di Ravenna; 🇮🇹 Ravenna, Italy

Stabilimento Ss. Annunziata; 🇮🇹 Taranto, Italy

Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI; 🇮🇹 Varese, Italy

Azienda Osp. S.Giovanni/Addolorata Roma; 🇮🇹 Roma, Italy

Azienda Ospedaliera "S. Maria"; 🇮🇹 Terni, Italy

Ente Eccl.Osp.Gen.Reg.'Miulli'; 🇮🇹 Acquaviva Delle Fonti, Bari, Italy

Ospedale Bianchi - Melacrino - Morelli; 🇮🇹 Reggio Di Calabria, Reggio Calabria, Italy

Ospedale Civile Di Ivrea; 🇮🇹 Ivrea, Torino, Italy

Ospedale Civile Ss. Antonio E Biagio Di Alessandria; 🇮🇹 Alessandria, Italy

Pres.Ospedal.Spedali Civili Brescia; 🇮🇹 Brescia, Italy

Stabilimento "Perrino"; 🇮🇹 Brindisi, Italy

Ospedale Armando Businco -; 🇮🇹 Cagliari, Italy

A.O. Universitaria Ospedale Vittorio Emanuele E Ferrarotto Di Catania; 🇮🇹 Catania, Italy

Nuovo Ospedale Garibaldi - Nesima; 🇮🇹 Catania, Italy

Osp.Generale Di Zona Valduce; 🇮🇹 Como, Italy

Presidio Ospedaliero Annunziata; 🇮🇹 Cosenza, Italy

Presidio Ospedaliero Matera; 🇮🇹 Matera, Italy

A.O. Universitaria Policlinico Di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliera S. Gerardo Di Monza; 🇮🇹 Monza, Italy

Irccs Istituto Oncologico Veneto (Iov); 🇮🇹 Padova, Italy

A.O. Universitaria Policlinico Giaccone Di Palermo; 🇮🇹 Palermo, Italy

A.O. "V. Cervello"; 🇮🇹 Palermo, Italy

Casa Di Cura La Maddalena Di Palermo; 🇮🇹 Palermo, Italy

A.O. Universitaria Di Parma; 🇮🇹 Parma, Italy

Ospedale Di S. Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Ospedale Di Rimini; 🇮🇹 Rimini, Italy

Irccs Istituto Regina Elena (Ifo); 🇮🇹 Roma, Italy

A.O. Universitaria Policlinico Di Sassari; 🇮🇹 Sassari, Italy

A.O. Universitaria Senese; 🇮🇹 Siena, Italy

Ematologia 1 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO; 🇮🇹 Torino, Italy

Ematologia 2 - A.O. UNIVERSITARIA S. GIOVANNI BATTISTA-MOLINETTE DI TORINO; 🇮🇹 Torino, Italy

Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI; 🇮🇹 Varese, Italy

Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori; 🇮🇹 Meldola, Forlì-Cesena, Italy

Irccs Ospedale Casa Sollievo Della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob); 🇮🇹 Rionero in Vulture, Potenza, Italy

Nuovo Ospedale Di Sassuolo S.P.A.; 🇮🇹 Sassuolo, Modena, Italy

P.O. Umberto I; 🇮🇹 Nocera Inferiore, Salerno, Italy

Asp Di Bolzano - Comprensorio Sanitario Di Bolzano; 🇮🇹 Bolzano, Italy

Ospedale Civile Spirito Santo; 🇮🇹 Pescara, Italy

A.O. Universitaria Pisana; 🇮🇹 Pisa, Italy

A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D'Ar; 🇮🇹 Salerno, Italy