The purpose of this study is to define an improvement in patients randomized in four different arms: Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
399
375 mg/m2 day 1
1200 mg/m2 day 1
70 mg/m2 day 1
1,4 mg/m2 (max 2 mg) day 1
100 mg day g 1-5
6 mg day +1
8 mg/m2/days 1-3
2000 mg/m2/12h day 1 - 3
5 μg/Kg/days +2
300 mg/m2 day -7
200 mg/m2/12 days -6,-5,-4,-3
100 mg/m2/12h days -6,-5,-4,-3
PBSC Reinfusion
750 mg/m2 day 1
50 mg/m2 day 1
1,4 mg/m2 (max 2 mg) day 1
Ospedale Umberto I - DH Oncoematologico
Nocera Inferiore, Salerno, Italy
Ospedale Civile Umberto I
Mestre, Venezia, Italy
Osp. Calvi, Noale
Mirano, Venezia, Italy
Az. Osp. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Cardinal Massaia
Asti, Italy
Centro di Riferimento Oncologico
To evaluate the activity of arms "R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT" and "R-MegaCHOP14/R-CHOP14" in terms of 2-years Failure Free Survival (FFS).
Time frame: 2 years
To evaluate the activity of arms "R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT" and "R-MegaCHOP14/R-CHOP14" in terms of 3-years Overall Survival (OS).
Time frame: 3 years
To evaluate the efficacy of two different dose-dense + Rituximab chemotherapy regimens in term of 2-years Failure Free Survival (FFS).
Time frame: 2 years
To evaluate the activity of the first four courses of two different dose dense + Rituximab chemotherapy regimens (standard dose R-CHOP14 or intensified dose R-MegaCHOP14) in terms of Overall Response Rate (ORR) and Complete Remission (RC).
Time frame: 2 years
To evaluate the efficacy of the four different induction arms in terms of 2-years FFS (exploratory analysis).
Time frame: 2 years
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Aviano - PN, Italy
Azienda Ospedale Policlinico Consorziale
Bari, Italy
IRCC Istituto tumori Ematologia
Bari, Italy
Osp. Degli Infermi
Biella, Italy
Ospedale Policlinico S. Orsola Malpighi
Bologna, Italy
...and 65 more locations