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BRIEF Bendamustine and Rituximab In Elderly Follicular

NCT01313611 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-03-07

No results posted yet for this study

Summary

The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden.

This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks

Conditions

Interventions

DRUG

Rituximab + bendamustine

Induction phase: rituximab and bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, Rituximab on Day 22, bendamustine on Day 29, Bendamustine on Day 30

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Pierre FEUGIER, MD · CHU Brabois, 54511 Vandoeuvre les Nancy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-10-31
Completion
2017-12-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT01313611 on ClinicalTrials.gov