Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma

NCT01523860 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-03-01

No results posted yet for this study

Summary

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.

Conditions

Interventions

DRUG

Rituximab, Mitoxantrone, Bendamustine

Rituximab will be supplied as 375 mg/sqm for i.v.administration.Mitoxantrone will be supplied as 8 mg/sqm for i.v.administration.Bendamustine will be supplied as 90 mg/sqm for i.v.administration

Sponsors & Collaborators

  • Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

    collaborator OTHER
  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Umberto Vitolo, MD · Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Italy

Study Locations

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Entities

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 NCT01523860 on ClinicalTrials.gov