Patient baseline characteristics and disposition
| Characteristic . | N = 64 . |
|---|---|
| Age, median (range), years | 71 (65-90) |
| Gender, males, n (%) | 40 (62.5) |
| Diagnosis, n (%) | |
| CLL | 59 (92.2) |
| SLL | 5 (7.8) |
| Bulky adenopathy*, n (%) | 7 (10.9) |
| Organomegaly, n (%) | |
| Enlarged spleen | 28 (43.8) |
| Enlarged liver | 7 (10.9) |
| Rai stage at screening, n (%) | |
| 0 | 3 (4.7) |
| I | 19 (29.7) |
| II | 14 (21.9) |
| III | 8 (12.5) |
| IV | 19 (29.7) |
| Unknown | 1 (1.6) |
| Prognostic factors, n (%) | |
| Unmutated IGHV | 37 (57.8) |
| del(17p) only | 2 (3.1) |
| TP53 mutation only | 3 (4.7) |
| Either del(17p) or TP53 mutation | 9 (14.1) |
| Both del(17p) and TP53 mutation | 4 (6.3) |
| Trisomy 12q | 16 (25.0) |
| del(13q) | 24 (37.5) |
| del(11q) | 10 (15.6) |
| NOTCH1 mutation | 8 (12.5) |
| SF3B1 mutation | 7 (10.9) |
| β2 μg,, median (range) mg/L | 4 (1.9-15.8) |
| Duration of idelalisib therapy, median (range), months | 22.4 (0.8-45.8+) |
| Treatment disposition, n (%) | |
| Completed cycle 2 (rituximab therapy) | 62 (96.9) |
| Completed primary study† | 43 (67.2) |
| Discontinued from primary study | 21 (32.8) |
| Enrolled in extension study | 41 (64.1) |
| Reason for early discontinuation, | |
| From primary study, n (%) | |
| Adverse event | 19 (29.7) |
| Withdrew consent | 1 (1.6) |
| Death | 3 (4.7) |
| From extension study, n (%) | |
| Disease progression | 4 (9.8) |
| Adverse event | 10 (24.4) |
| Withdrew consent | 2 (4.9) |
| Investigator request | 1 (2.4) |
| Death | 1 (2.4) |
| Characteristic . | N = 64 . |
|---|---|
| Age, median (range), years | 71 (65-90) |
| Gender, males, n (%) | 40 (62.5) |
| Diagnosis, n (%) | |
| CLL | 59 (92.2) |
| SLL | 5 (7.8) |
| Bulky adenopathy*, n (%) | 7 (10.9) |
| Organomegaly, n (%) | |
| Enlarged spleen | 28 (43.8) |
| Enlarged liver | 7 (10.9) |
| Rai stage at screening, n (%) | |
| 0 | 3 (4.7) |
| I | 19 (29.7) |
| II | 14 (21.9) |
| III | 8 (12.5) |
| IV | 19 (29.7) |
| Unknown | 1 (1.6) |
| Prognostic factors, n (%) | |
| Unmutated IGHV | 37 (57.8) |
| del(17p) only | 2 (3.1) |
| TP53 mutation only | 3 (4.7) |
| Either del(17p) or TP53 mutation | 9 (14.1) |
| Both del(17p) and TP53 mutation | 4 (6.3) |
| Trisomy 12q | 16 (25.0) |
| del(13q) | 24 (37.5) |
| del(11q) | 10 (15.6) |
| NOTCH1 mutation | 8 (12.5) |
| SF3B1 mutation | 7 (10.9) |
| β2 μg,, median (range) mg/L | 4 (1.9-15.8) |
| Duration of idelalisib therapy, median (range), months | 22.4 (0.8-45.8+) |
| Treatment disposition, n (%) | |
| Completed cycle 2 (rituximab therapy) | 62 (96.9) |
| Completed primary study† | 43 (67.2) |
| Discontinued from primary study | 21 (32.8) |
| Enrolled in extension study | 41 (64.1) |
| Reason for early discontinuation, | |
| From primary study, n (%) | |
| Adverse event | 19 (29.7) |
| Withdrew consent | 1 (1.6) |
| Death | 3 (4.7) |
| From extension study, n (%) | |
| Disease progression | 4 (9.8) |
| Adverse event | 10 (24.4) |
| Withdrew consent | 2 (4.9) |
| Investigator request | 1 (2.4) |
| Death | 1 (2.4) |