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 |
| 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.