Patient baseline characteristics
| Characteristic . | Value . |
|---|---|
| Evaluable for safety, n | 51 |
| Evaluable for PFS, n* | 50 |
| Measurable disease at study entry, n | 36 |
| Age, median (range), y | 70 (48-96) |
| Time from CLL diagnosis to enrollment, median (range), mo | 93 (11-285) |
| Males/females, n | 28/23 |
| ECOG PS score 0/1/2, n | 23/24/4 |
| Creatinine, median (range), mg/dL | 0.94 (0.5-1.63) |
| Unmutated IGHV, % | 65 |
| Bulky disease | 21 (41) |
| del(17p) and TP53 mutated | 5 (10) |
| del(17p) without TP53 mutation | 2 (4) |
| TP53 mutated without del(17p) | 5 (10) |
| del(11q) | 9 (18) |
| Evaluable for next-generation sequencing, n | 46 |
| Genetic mutations at baseline | |
| ATM | 11 (24) |
| BTK | 1 (2) |
| NOTCH1 | 4 (9) |
| PLCG2 | 2 (4) |
| SF3B1 | 7 (15) |
| TP53 | 10 (22) |
| Prior therapies, median (range) | 2 (1-7) |
| Prior BTKi | 44 (86) |
| Prior PI3Ki | 7 (14) |
| Time on prior KI, median (range), mo | 9 (0.7-38) |
| Time from discontinuation of prior KI to enrollment, median (range), mo | 3 (1-12) |
| Required treatment within 6 mo of prior KI | 39 (76) |
| Characteristic . | Value . |
|---|---|
| Evaluable for safety, n | 51 |
| Evaluable for PFS, n* | 50 |
| Measurable disease at study entry, n | 36 |
| Age, median (range), y | 70 (48-96) |
| Time from CLL diagnosis to enrollment, median (range), mo | 93 (11-285) |
| Males/females, n | 28/23 |
| ECOG PS score 0/1/2, n | 23/24/4 |
| Creatinine, median (range), mg/dL | 0.94 (0.5-1.63) |
| Unmutated IGHV, % | 65 |
| Bulky disease | 21 (41) |
| del(17p) and TP53 mutated | 5 (10) |
| del(17p) without TP53 mutation | 2 (4) |
| TP53 mutated without del(17p) | 5 (10) |
| del(11q) | 9 (18) |
| Evaluable for next-generation sequencing, n | 46 |
| Genetic mutations at baseline | |
| ATM | 11 (24) |
| BTK | 1 (2) |
| NOTCH1 | 4 (9) |
| PLCG2 | 2 (4) |
| SF3B1 | 7 (15) |
| TP53 | 10 (22) |
| Prior therapies, median (range) | 2 (1-7) |
| Prior BTKi | 44 (86) |
| Prior PI3Ki | 7 (14) |
| Time on prior KI, median (range), mo | 9 (0.7-38) |
| Time from discontinuation of prior KI to enrollment, median (range), mo | 3 (1-12) |
| Required treatment within 6 mo of prior KI | 39 (76) |
Unless otherwise noted, data are n (%).
ECOG PS, Eastern Cooperative Oncology Group Performance Status.
One patient with confirmed Richter’s transformation at enrollment (not eligible); excluded from PFS analysis.