Patient characteristics and disposition
| Description . | N = 54 . |
|---|---|
| Sex, n (%) | |
| Male | 45 (83.3) |
| Female | 9 (16.7) |
| Age, y, median (range) | 62.5 (37-82) |
| WHO performance status score, n (%) | |
| 0 | 17 (31.5) |
| 1 | 32 (59.3) |
| 2 | 5 (9.3) |
| Stage of disease at baseline (Rai classification) | |
| Low risk | 5 (9.3) |
| Intermediate risk | 12 (22.2) |
| High risk | 36 (66.7) |
| Missing | 1 (1.9) |
| Extent of CLL, n (%) | |
| Bulky lymphadenopathy (≥1 node ≥5 cm in diameter) | 43 (79.6) |
| Splenomegaly | 20 (37.0) |
| Hepatomegaly | 3 (5.6) |
| Thrombocytopenia (platelets <100 × 109/L) | 34 (63.0) |
| Anemia (Hb <110 g/L) | 25 (46.2) |
| Neutropenia (ANC <1.5 × 109/L) | 15 (27.7) |
| ALC cells × 109/L, median (range) | 10.8 (0.1-185.2) |
| CLL genetics, n (%) | |
| Unmutated IgHV | 49 (90.7) |
| del17p and/or TP53 mutation | 13 (20.4) |
| Prior therapies, n, median (range) | 5 (2-14) |
| Prior therapy type, n (%) | |
| Purine analog | 54 (100.0) |
| Rituximab | 52 (96.0) |
| Alkylating agent | 47 (87.0) |
| Alemtuzumab | 19 (35.2) |
| Anthracycline/anthracenedione | 18 (33.3) |
| Disease status (investigator judgment), n (%) | |
| Relapsed | 16 (29.6) |
| Refractory (to the most recent prior therapy) | 38 (70.4) |
| Idelalisib starting dose level, n (%) | |
| 50 mg/dose bid | 5 (9.3) |
| 100 mg/dose bid | 11 (20.4) |
| 300 mg/dose qd | 10 (18.5) |
| 150 mg/dose bid | 11 (20.4) |
| 200 mg/dose bid | 10 (18.5) |
| 350 mg/dose bid | 7 (13.0) |
| Duration of idelalisib therapy, mo, mean (range) | 15 (0.2-48.7) |
| Treatment disposition, n (%) | |
| Completed primary study (≥48 wk of idelalisib therapy) | 25 (46.3) |
| Discontinued primary study therapy | 29 (53.7) |
| Enrolled in extension study | 23 (38.9) |
| Ongoing | 8 (14.8) |
| Discontinued extension study therapy | 15 (27.8) |
| Primary reasons for discontinuation from primary or extension study therapy* | |
| Disease progression | 25† (46.3) |
| AE | 7‡ (12.9) |
| Death | 4 (7.4) |
| Patient request | 3 (5.6) |
| Other (lost to follow-up, other therapy, referred for transplantation) | 3 (5.6) |
| Investigator request | 2§ (3.7) |
| Description . | N = 54 . |
|---|---|
| Sex, n (%) | |
| Male | 45 (83.3) |
| Female | 9 (16.7) |
| Age, y, median (range) | 62.5 (37-82) |
| WHO performance status score, n (%) | |
| 0 | 17 (31.5) |
| 1 | 32 (59.3) |
| 2 | 5 (9.3) |
| Stage of disease at baseline (Rai classification) | |
| Low risk | 5 (9.3) |
| Intermediate risk | 12 (22.2) |
| High risk | 36 (66.7) |
| Missing | 1 (1.9) |
| Extent of CLL, n (%) | |
| Bulky lymphadenopathy (≥1 node ≥5 cm in diameter) | 43 (79.6) |
| Splenomegaly | 20 (37.0) |
| Hepatomegaly | 3 (5.6) |
| Thrombocytopenia (platelets <100 × 109/L) | 34 (63.0) |
| Anemia (Hb <110 g/L) | 25 (46.2) |
| Neutropenia (ANC <1.5 × 109/L) | 15 (27.7) |
| ALC cells × 109/L, median (range) | 10.8 (0.1-185.2) |
| CLL genetics, n (%) | |
| Unmutated IgHV | 49 (90.7) |
| del17p and/or TP53 mutation | 13 (20.4) |
| Prior therapies, n, median (range) | 5 (2-14) |
| Prior therapy type, n (%) | |
| Purine analog | 54 (100.0) |
| Rituximab | 52 (96.0) |
| Alkylating agent | 47 (87.0) |
| Alemtuzumab | 19 (35.2) |
| Anthracycline/anthracenedione | 18 (33.3) |
| Disease status (investigator judgment), n (%) | |
| Relapsed | 16 (29.6) |
| Refractory (to the most recent prior therapy) | 38 (70.4) |
| Idelalisib starting dose level, n (%) | |
| 50 mg/dose bid | 5 (9.3) |
| 100 mg/dose bid | 11 (20.4) |
| 300 mg/dose qd | 10 (18.5) |
| 150 mg/dose bid | 11 (20.4) |
| 200 mg/dose bid | 10 (18.5) |
| 350 mg/dose bid | 7 (13.0) |
| Duration of idelalisib therapy, mo, mean (range) | 15 (0.2-48.7) |
| Treatment disposition, n (%) | |
| Completed primary study (≥48 wk of idelalisib therapy) | 25 (46.3) |
| Discontinued primary study therapy | 29 (53.7) |
| Enrolled in extension study | 23 (38.9) |
| Ongoing | 8 (14.8) |
| Discontinued extension study therapy | 15 (27.8) |
| Primary reasons for discontinuation from primary or extension study therapy* | |
| Disease progression | 25† (46.3) |
| AE | 7‡ (12.9) |
| Death | 4 (7.4) |
| Patient request | 3 (5.6) |
| Other (lost to follow-up, other therapy, referred for transplantation) | 3 (5.6) |
| Investigator request | 2§ (3.7) |