Table 1.

Key clinical trials with ibrutinib in CLL

Name	Phase	Population	Response	Ref
N/A	IB/II	R/Rb	71% ORRc by standard response criteria. Additional 18% partial response with persistent lymphocytosis	[62]
Resonate	III	R/R	Demonstrated that ibrutinib was superior to ofatumumab for response rate, PFSd and OSe	[63]
N/A	I/IB	TNf ≥ 65 years	90% achieved objective response or partial response with persistent lymphocytosis	[64]
Resonate-2	III	TN ≥ 65 years	Demonstrated that ibrutinib was superior to chlorambucil for overall response rate, PFS and OS	[65]
Helios	III	R/R	Ibrutinib + bendamustine/rituximab superior to bendamustine/rituximab for PFS and OS	[66, 67]
Alliance A041202	III	TN ≥ 65 years	Ibrutinib superior to bendamustine + rituximab for PFS. No difference between ibrutinib or ibrutinib + rituximab for PFS	[68]
ECOG 1912	III	TN ≤ 70 years	Ibrutinib + rituximab superior to CIT for PFS and OS at interim analysis	[69]
iLLUMINATE	III	TN ≥ 65 years or < 65 years with coexisting conditions	Ibrutinib + obinutuzumab superior to chlorambucil + obinutuzumab for PFS	[70]

^aN/A: not applicable;

^bR/R: relapsed/refractory;

^cORR: overall response rate;

^dPFS: progression-free survival;

^eOS: overall survival;

^fTN: treatment naïve