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

NCT01990144 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-11-21

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-02-28
Completion
2016-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01990144 on ClinicalTrials.gov