This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL). The study includes and induction phase and a consolidation phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
INDUCTION PHASE Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week): Rituximab: 375 mg/sqm iv, day 1\* Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice Repeat cycles every 28 days for a total of 4 cycles \*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8. CONSOLIDATION PHASE Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week): Rituximab: 375 mg/sqm iv day 1 Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice Rituximab two monthly doses Rituximab: 375 mg/sqm iv week 24 and 28
SC Ematologia - AO SS. Antonio e Biagio e C. Arrigo
Complete remission rate (CR)
Evaluated at the end of treatment
Time frame: 5 months
Safety analysis
Evaluated during and at the end of treatment. Percentage of patients with adverse, hematological and non-hematological toxic events
Time frame: 5 months
Overall response rate (ORR)
Evaluated at the end of treatment. Complete plus partial remission.
Time frame: 5 months
Overall survival (OS)
Dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.
Time frame: at 2 years
Progression free survival (PFS)
Progression, relapse or dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.
Time frame: at 2 years
Disease free survival (PFS)
Relapse or dead for any causes from the end of treatment, for patients in CR after B+R. Evaluated by means of Kaplan-Meier method.
Time frame: at 2 years
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Alessandria, AL, Italy
SC Ematologia Spedali Civili
Brescia, BS, Italy
Divisione di Ematologia e Trapianti, Ospedale San Maurizio
Bolzano, BZ, Italy
Divisione di Ematologia, Centro Trapianto di Cellule Staminali
San Giovanni Rotondo, Foggia, Italy
Divisione Ematologia I , Ospedale San Martino
Genova, GE, Italy
S.C. Ematologia Azienda Ospedaliera Papardo
Messina, ME, Italy
Divisione di Oncologia Medica ed Ematologia, Istituto Clinico Humanitas
Rozzano, Milano, Italy
Divisione di Ematologia Ospedale Niguarda
Milan, MI, Italy
Centro Oncologico Modenese
Modena, MO, Italy
Ematologia Azienda Ospedaliero Universitaria Paolo Giaccone
Palermo, PA, Italy
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