584 / 1631
SABRINA: 2-stage randomised phase III study in untreated
FL
Rituximab IV
(375 mg/m
2
)
Rituximab SC
(1400 mg)
N=410
untreated FL
patients
requiring
treatment
according to
the GELF
criteria
Maintenance
Rituximab IV,
q2m x 2 years
CR/CRu/PR
8 x R-CHOP/R-CVP
R
A
N
D
O
M
I
S
E
D
*
Maintenance
Rituximab SC,
q2m x 2 years
96 weeks
follow-up
1:1
•
Stage 1 & 2 same inclusion/exclusion criteria
•
Stage 1 & 2 same design, except PK (more intensive in stage 1)
•
Pooled stage 1 & 2 data analysis pre-planned to allow assessing
efficacy and safety in most robust patient population
205 patients enrolled:
(stage 1 n=64; stage 2 n=141)
205 patients enrolled:
(stage 1 n=63; stage 2 n=142)
Focus on pooled stage 1 & 2 data
*Patients stratified according to Follicular Lymphoma International Prognostic (FLIPI) score, chemotherapy and region;
CR = complete response; GELF = Groupe d'Etudes des Lymphomes Folliculaires; PK = pharmacokinetic; PR = partial response; CHOP =
cyclophosphamide/doxorubicin/vincristine/prednisone; CVP = cyclophosphamide/vincristine/prednisone; IV = intravenous
Davies A, et al. Lancet Oncol 2014