Table 1.

Phase 2 and 3 trials in relapsed CLL for approval of targeted drugs alone or in combination with CD20 antibodies

Treatment	Trial name	N patients	Age,* y	ORR, %	CR, %	uMRD, %	PFS†	PFS	OS	Ref.
Ibrutinib	Not applicable	101	64	89	10	NA	51	44% at 5 y	60% at 5 y	1
Ibrutinib	RESONATE 1	195	67	91	9	NA	NR	59% at 3 y	74% at 3 y	2
Ofatumumab	RESONATE 1	196	67	4	0	NA	4.9	3% at 3 y	65% at 3 y
Acalabrutinib	ASCEND	155	67	88	0	NA	NR	88% at 1 y	94% at 1 y	3
BR/idelalisib + rituximab	ASCEND	155	67	77	1	NA	16.5	68% at 1 y	91% at 1 y
Idelalisib + rituximab	116	110	71	84	1	NA	19.4	—	40.6 median	4
Placebo + rituximab	116	110	71	15	0	NA	6.5	—	30.6 median
Duvelisib	DUO	160	69	74	1	NA	13.3	—	86% at 1 y	5
Ofatumumab	DUO	159	69	45	0	NA	9.9	—	86% at 1 y
Venetoclax	M13-982	153‡	67	77	20	30	NR	54% at 2 y	73% at 2 y	6
Venetoclax + rituximab	MURANO	194	65	92	8	62	NR	85% at 2 y	92% at 2 y	7
BR	MURANO	195	65	72	4	13	17.0	63% at 2 y	87% at 2 y

CR, complete response; NA, not analyzed; NR, not reached; ORR, overall response rate; OS, overall survival; uMRD, undetectable minimal residual disease.

^*Median progression-free survival (PFS).

^†Median months.

^‡Including only patients with del(17p).