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)

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

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

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

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

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

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

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

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

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

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

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