493 / 1835
Eligible patients:
♦
CD20-postiive FL, WM, MZL,
SLL, MCL (elderly)
♦
No previous treatment
♦
Stage III or IV
R
A
N
D
O
M
I
s
E
Bendamustine-Rituximab (BR)
Bendamustine 90 mg/m
2
days 1-2
Rituximab 375 mg/m
2
day 1
CHOP-Rituximab (R-CHOP)
Cyclophosphamide 750 mg/m
2
day 1
Doxorubicin 50 mg/m
2
day 1
Vincristine 1.4 mg/m
2
day 1
Prednisone 100 mg/days days 1-5
Rituximab 375 mg/m
2
day 1
Primary objective
♦
To prove the
non-inferiority of BR vs. R-CHOP
defined as a decrease of < 10% in progression-
free survival (PFS) after 3 years
Secondary objectives
♦
Time to next treatment (TTNT), event-free survival (EFS), overall survival (OS)
♦
Acute and late toxicities, infectious complications
♦
(n = 549)
Mantle Cell Lymphomas (MCL): Updated Results from the StiL
NHL1 Study