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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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
Complete Response (CR) Rate at the end of the consolidation phase
Proportion of CR according to the Cheson 2007 response criteria
Time frame: 6 months
Progression-free survival (PFS)
PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause.
Time frame: 24 months
Molecular response rate (Bcl2/IgH rearrangement)
Rate of conversion to molecular remission by qualitative and quantitative PCR only in patients with a positive marker at baseline
Time frame: 24 months
Molecular relapse rate
Rate of conversion to molecular relapse measured by PCR only in patients with a positive marker at baseline
Time frame: 24 moths
Incidence of grade 3 or greater overall toxicities measured by CTCAE v.3.0
Time frame: 24 months
Overall survival (OS)
OS will be measured from the day of enrolment to the date of death due to any cause.
Time frame: 24 moths
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Divisione di Ematologia Ospedale SS. Antonio e Biagio
Alessandria, Alessandria, Italy
SOS Ematologia Ospedale C. Massaia
Asti, Asti, Italy
Ematologia con Trapianto, Università di Bari
Bari, Bari, Italy
Medicina Interna, Ospedale degli Infermi
Biella, Biella, Italy
Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola
Bologna, Bologna, Italy
Divisione di Ematologia e TMO, Ospedale di Bolzano
Bolzano, Bolzano, Italy
S.C. di Ematologia, Spedali Civili
Brescia, Brescia, Italy
Divisione di Ematologia, Ospedale Businco
Cagliari, Cagliari, Italy
Divisione di Ematologia, Ospedale di Catania
Catania, Catania, Italy
Azienda Ospedaliera Santa Croce e Carle
Cuneo, Cuneo, Italy
...and 27 more locations