A Phase 3 interventional study of Rituximab and Ciclofosfamide in Diffuse Large B-Cell Lymphoma and IPI≥2, sponsored by Fondazione Italiana Linfomi - ETS. Status unknown at 75 sites in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-02-15.
Sponsored by Fondazione Italiana Linfomi - ETS · Phase 3, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 399 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 89 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Histological diagnosis of:
R-MegaCHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
Drug: Rituximab · Drug: Ciclofosfamide · Drug: Doxorubicina · Drug: Vincristina · Drug: Prednisone · Drug: Pegfilgrastim · Drug: Mitoxantrone · Drug: ARA-C · Drug: Lenograstim · Drug: BCNU · Drug: VP-16 · Procedure: ASCT
R-CHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
Drug: Rituximab · Drug: Vincristina · Drug: Prednisone · Drug: Pegfilgrastim · Drug: Lenograstim · Drug: BCNU · Drug: ARA-C · Drug: VP-16 · Procedure: ASCT · Drug: Ciclofosfamide · Drug: Doxorubicina
R-MegaCHOP14 x 4 Restaging + R-MegaCHOP x 2
Drug: Rituximab · Drug: Ciclofosfamide · Drug: Doxorubicina · Drug: Vincristina · Drug: Prednisone · Drug: Pegfilgrastim · Drug: Mitoxantrone · Drug: ARA-C
R-CHOP14 x 4 Restaging + R-CHOP14 x 4
Drug: Rituximab · Drug: Vincristina · Drug: Prednisone · Drug: Ciclofosfamide · Drug: Doxorubicina
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
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
This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Fondazione Italiana Linfomi - ETS