Table 6.

Major ongoing trials evaluating fixed-duration targeted therapies against CIT or continuous targeted therapies

Trial	N pts	Trial population		Compared arms	Primary end point
CLL13- GAIA GCLLSG NCT02950051	926	≥18 y fit/TP53 abn excluded	vs vs vs	CIT: FCR/BR × 6 cycles RVe: VEN-R (12 mo) GVe: VEN-O (12 mo) GIVe: VEN-O + I (up to 36 mo; VEN 12 mo)	MRD at mo 15 (CIT vs GVe) PFS (CIT vs GIVe)
ACE-CL-311 AstraZeneca NCT03836261	780	≥18 y fit/TP53 abn excluded	vs vs	CIT: FCR/BR × 6 cycles AV: VEN-O + acalabrutinib (15 mo; VEN 12 mo) AVG: VEN-O + acalabrutinib (15 mo; VEN 12 mo)	PFS (CIT vs AV)
CRISTALLO Hoffmann La Roche NCT04285567	165	≥18 y fit/TP53 abn excluded	vs	CIT: FCR or BR (if ≥65 y) × 6 cycles VG: VEN-O (12 mo)	BM MRD at mo 15
FILO ERADIC NCT04010668	120	≥18 y fit/TP53 abn excluded	vs	CIT: FCR × 6 cycles VI: VEN-I (15 or 27 mo according to MRD)	BM MRD at mo 27
NCRI UK CLL10 FLAIR CRUK/12/037	1516	≤75 y fit/eGFR >30 mL/min del(17p) <20%	vs vs	CIT: FCR × 6 cycles IR → I*: I + ritux → I (until progression) VI: VEN-I (flexible duration according to MRD) * arm IR replaced by I monotherapy in 2018	PFS
ALLIANCE A041702 NCT03737981	454	≥70 y	vs	IO: I + O (until progression) IVO: VEN-O + I (15 mo; VEN 12 mo)	PFS
ECOG-ACRIN EA9161 NCT03701282	720	18-69 y del(17p) excluded	vs	IO: I + O (until progression) IVO: VEN-O + I (19 mo; VEN 12 mo)	PFS
GCLLSG CLL17 NCT04608318	897	≥18 y fit and unfit w/or w/o TP53 abn	vs vs	I: I (until progression) VG: VEN-O (12 mo) VI: VEN-I (15 mo; VEN 12 mo)	PFS

abn, abnormalities; A, acalabrutinib; I, ibrutinib; O, obinutuzumab; R, rituximab; VEN, venetoclax.