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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT01523860
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Mitoxantrone, Bendamustine — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Feb 2016
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
76 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    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.

Primary Outcome Measure

Complete Response (CR) Rate at the end of the consolidation phase [ Time Frame: 6 months ]

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