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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT01990144
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Bendamustine+Rituximab — DRUG
    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 Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Nov 2013
Primary completion
Feb 28, 2014
Completion
Feb 29, 2016

Study Design

Enrollment
49 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

To evaluate the activity of R-B combination in terms of complete response rate (CRR). [ Time Frame: 4 years ]

Central Contacts

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