The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms: R-CVP vs R-CHOP vs R-FM.
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
534
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,
Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.
Time frame: 2 years
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -
Time frame: 3 years
Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP
Time frame: 2 years
Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.
Time frame: 2 years
Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.
Time frame: 2 years
Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.
Time frame: 2 years
Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.
Time frame: 2 years
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Terni, Terni, Italy
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Presidio Ospedaliero C.Massaia di Asti
Asti, Italy
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Aviano, Italy
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Bari, Italy
Divisione Medicina B Ospedale degli Infermi
Biella, Italy
Policlinico Sant'Orsola - Istituto di Ematologia e Oncologia medica L.e A. Seragnoli
Bologna, Italy
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Bolzano, Italy
A.O.Spedali civili di Brescia
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...and 72 more locations