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

Diffuse Large B-cell Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01990144
• Other study ID #: FIL_R-BENDA FRAIL
• Status: Recruiting
• Phase: Phase 2
• First received: November 15, 2013
• Last updated: November 15, 2013
• Start date: November 2011
• Est. completion date: February 2016

Study information

• Verified date: November 2013
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: Marco Calabrese, Dr
• Phone: +39 0131 206129
• Email: segreteria[@]filinf.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: February 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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.

Locations

Country	Name	City	State
Italy	Ente Eccl.Osp.Gen.Reg.'Miulli'	Acquaviva Delle Fonti	Bari
Italy	Ospedale Civile Ss. Antonio E Biagio Di Alessandria	Alessandria
Italy	Irccs Centro Di Riferimento Oncologico (Cro)	Aviano	Pordenone
Italy	Asp Di Bolzano - Comprensorio Sanitario Di Bolzano	Bolzano
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	Ospedale Generale Di Zona	Civitanova Marche	Macerata
Italy	Osp.Generale Di Zona Valduce	Como
Italy	Presidio Ospedaliero Annunziata	Cosenza
Italy	A.O. Universitaria S. Martino Di Genova	Genova
Italy	Ospedale Civile Di Ivrea	Ivrea	Torino
Italy	Presidio Ospedaliero Matera	Matera
Italy	Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori	Meldola	Forlì-Cesena
Italy	A.O. Universitaria Policlinico Martino Di Messina	Messina
Italy	Azienda Ospedaliera Papardo	Messina
Italy	Irccs Istituto Nazionale Dei Tumori (Int)	Milano
Italy	Ospedale Ca` Granda-Niguarda	Milano
Italy	Ospedale S. Carlo Borromeo	Milano
Italy	A.O. Universitaria Policlinico Di Modena	Modena
Italy	Azienda Ospedaliera S. Gerardo Di Monza	Monza
Italy	P.O. Umberto I	Nocera Inferiore	Salerno
Italy	Irccs Istituto Oncologico Veneto (Iov)	Padova
Italy	A.O. "V. Cervello"	Palermo
Italy	A.O. Universitaria Policlinico Giaccone Di Palermo	Palermo
Italy	Casa Di Cura La Maddalena Di Palermo	Palermo
Italy	A.O. Universitaria Di Parma	Parma
Italy	Ospedale Civile Spirito Santo	Pescara
Italy	Ausl Di Piacenza	Piacenza
Italy	A.O. Universitaria Pisana	Pisa
Italy	Ospedale S. Maria Delle Croci Di Di Ravenna	Ravenna
Italy	Ospedale Bianchi - Melacrino - Morelli	Reggio Di Calabria	Reggio Calabria
Italy	Ospedale Di S. Maria Nuova	Reggio Emilia
Italy	Ospedale Di Rimini	Rimini
Italy	Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)	Rionero in Vulture	Potenza
Italy	Azienda Osp. S.Giovanni/Addolorata Roma	Roma
Italy	Irccs Istituto Regina Elena (Ifo)	Roma
Italy	Ospedale S. Eugenio	Roma
Italy	A.O.Oo.Rr.S.Giovanni Di Dio E Ruggi D`Ar	Salerno
Italy	Irccs Ospedale Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Foggia
Italy	A.O. Universitaria Policlinico Di Sassari	Sassari
Italy	Nuovo Ospedale Di Sassuolo S.P.A.	Sassuolo	Modena
Italy	A.O. Universitaria Senese	Siena
Italy	Stabilimento Ss. Annunziata	Taranto
Italy	Azienda Ospedaliera "S. Maria"	Terni
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	Ospedale S. Nicola Pellegrino Di Trani	Trani	Barletta
Italy	Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI	Varese
Italy	Oncologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the activity of R-B combination in terms of complete response rate (CRR).		4 years	Yes
Primary	To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.		4 years	Yes
Secondary	To evaluate progression free survival (PFS)		4 years	Yes
Secondary	To evaluate overall survival (OS)		4 years	Yes