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
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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