731 / 1631
•
Phase II single-arm monotherapy study in patients with R/R iNHL
•
Accrual completed October 2012
•
Tumour assessments:
-
Week 0, 8, 16, 24, 36 and 48, then every 12 weeks thereafter
-
Evaluated by independent review committee (IRC)
-
2 radiologists with adjudication, if needed, and clinical review
•
Primary endpoint:
Overall response rate (ORR)
•
Secondary endpoints:
Duration of response (DOR), progression-free survival (PFS), safety
Idelalisib in Double-Refractory iNHL
Gopal A
et al.
ASH 2014, Abstract #1708
Week
0
48
N=125
Idelalisib 150mg BID
Study 101-09
Continuous therapy
Therapy maintained until progression
Long-term follow-up