Table 2.

Key clinical trials of approved BCL-2 inhibitors for the treatment of CLL

Agent	Trial name	Trial design and patients	Outcomes	Citation
Venetoclax (second-line or later monotherapy)	NCT01889186	Phase 2 single-arm study of the safety and efficacy of venetoclax in patients with del(17p) relapsed or refractory CLL	ORR: 12.1-month median follow-up, 79.4%; final, 77%  24-month PFS: 54%  SAEs: 12.1-month median follow-up, 55%; final, 58%	[49, 50]
Venetoclax (first-line combination therapy)	CLL14 (NCT02242942)	Phase 3 study of the efficacy and safety of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in treatment-naïve patients with CLL who have coexisting conditions	Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab:  24-month PFS: 88.2% versus 64.1%   Results were similar for TP53 deletion/mutation or unmutated IGHV  Grade ≥ 3 AEs: 78.8% versus 76.6%	[51]
Venetoclax (second-line or greater combination therapy)	MURANO (NCT02005471)	Phase 3 study of the efficacy and safety of venetoclax plus rituximab versus bendamustine plus rituximab in patients with relapsed or refractory CLL/SLL	Venetoclax plus rituximab versus bendamustine plus rituximab:  24-month PFS: 84.9% versus 36.3%   Results were similar for TP53 deletion or unmutated IGHV  Grade ≥ 3 AEs: 82.0% versus 70.2%	[50]

AE adverse event, BCL-2 B-cell lymphoma 2, CLL chronic lymphocytic lymphoma, IGHV, immunoglobulin heavy chain, ORR overall response rate, PFS progression-free survival, SAE serious adverse event, SLL small lymphocytic lymphoma