Baseline characteristics
| . | CLL2-BIO . | CLL2-BIG . | CLL2-BAG . | Total . |
|---|---|---|---|---|
| Analysis population (patients with del(17p)/TP53 mut | 21 | 13 | 17 | 51 |
| Age, y | ||||
| Median (range) | 68 (49-81) | 67 (55-81) | 56 (42-73) | 64 (42-81) |
| Patients aged >65 (%) | 12 (57) | 7 (54) | 3 (18) | 22 (43) |
| Sex | ||||
| Male patients (%) | 14 (67) | 6 (46) | 12 (71) | 32 (63) |
| ECOG performance status 1 or 2 (%) | 12 (57) | 5 (38) | 7 (41) | 24 (47) |
| CIRS comorbidity score | ||||
| Median (range) | 4 (1-9) | 4 (0-10) | 2 (0-14) | 3 (0-14) |
| Patients with CIRS >6 (%) | 4 (19) | 3 (23) | 1 (6) | 8 (16) |
| Creatinine clearance | ||||
| Median, mL/min | 80.5 | 77.8 | 79.9 | 79.9 |
| Patients with creatinine clearance <70 mL/min (%) | 6 (29) | 4 (31) | 5 (29) | 15 (29) |
| Previous therapies | ||||
| Patients with ≥1 prior therapy (%) | 13 (62) | 9 (69) | 11 (65) | 33 (65) |
| Patients with prior treatment, median (range) | 2 (1-5) | 1 (1-5) | 3 (1-9) | 2 (1-9) |
| Binet stage (%) | ||||
| A | 5 (24) | 2 (15) | 7 (41) | 14 (28) |
| B | 8 (38) | 2 (15) | 3 (18) | 13 (26) |
| C | 8 (38) | 9 (69) | 7 (41) | 24 (47) |
| Presence of B symptoms (%) | 9 (43) | 3 (23) | 8 (47) | 20 (39) |
| Serum parameters (%) | ||||
| Thymidine kinase >10 U/L | 19 (95) | 12 (92) | 16 (94) | 47 (94) |
| β2-microglobulin >3.5 mg/L | 13 (62) | 7 (54) | 9 (53) | 29 (58) |
| FISH cytogenetics, Döhner model (%) | ||||
| del(17p) | 12 (57) | 8 (62) | 11 (65) | 31 (61) |
| del(11q) | 2 (10) | 0 | 2 (12) | 4 (8) |
| Trisomy 12 | 0 | 0 | 1 (6) | 1 (2) |
| Normal | 4 (19) | 3 (23) | 2 (12) | 9 (18) |
| del(13q) | 3 (14) | 2 (15) | 1 (6) | 6 (12) |
| Molecular genetics (%) | ||||
| IGHV unmutated | 14 (67) | 9 (69) | 15 (88) | 38 (75) |
| TP53 mutated | 20 (95) | 12 (92) | 17 (100) | 49 (96) |
| NOTCH1 mutated | 2 (10) | 2 (15) | 2 (12) | 6 (12) |
| SF3B1 mutated | 4 (19) | 2 (15) | 3 (18) | 9 (18) |
| Complex karyotype, ≥3 aberrations (%) | 13 (68)* | NK* | 10 (59) | 23 (64)* |
| CLL-IPI (%) | ||||
| High | 3 (15) | 3 (23) | 5 (29) | 11 (22) |
| Very high risk | 17 (85) | 10 (77) | 12 (71) | 39 (78) |
| . | CLL2-BIO . | CLL2-BIG . | CLL2-BAG . | Total . |
|---|---|---|---|---|
| Analysis population (patients with del(17p)/TP53 mut | 21 | 13 | 17 | 51 |
| Age, y | ||||
| Median (range) | 68 (49-81) | 67 (55-81) | 56 (42-73) | 64 (42-81) |
| Patients aged >65 (%) | 12 (57) | 7 (54) | 3 (18) | 22 (43) |
| Sex | ||||
| Male patients (%) | 14 (67) | 6 (46) | 12 (71) | 32 (63) |
| ECOG performance status 1 or 2 (%) | 12 (57) | 5 (38) | 7 (41) | 24 (47) |
| CIRS comorbidity score | ||||
| Median (range) | 4 (1-9) | 4 (0-10) | 2 (0-14) | 3 (0-14) |
| Patients with CIRS >6 (%) | 4 (19) | 3 (23) | 1 (6) | 8 (16) |
| Creatinine clearance | ||||
| Median, mL/min | 80.5 | 77.8 | 79.9 | 79.9 |
| Patients with creatinine clearance <70 mL/min (%) | 6 (29) | 4 (31) | 5 (29) | 15 (29) |
| Previous therapies | ||||
| Patients with ≥1 prior therapy (%) | 13 (62) | 9 (69) | 11 (65) | 33 (65) |
| Patients with prior treatment, median (range) | 2 (1-5) | 1 (1-5) | 3 (1-9) | 2 (1-9) |
| Binet stage (%) | ||||
| A | 5 (24) | 2 (15) | 7 (41) | 14 (28) |
| B | 8 (38) | 2 (15) | 3 (18) | 13 (26) |
| C | 8 (38) | 9 (69) | 7 (41) | 24 (47) |
| Presence of B symptoms (%) | 9 (43) | 3 (23) | 8 (47) | 20 (39) |
| Serum parameters (%) | ||||
| Thymidine kinase >10 U/L | 19 (95) | 12 (92) | 16 (94) | 47 (94) |
| β2-microglobulin >3.5 mg/L | 13 (62) | 7 (54) | 9 (53) | 29 (58) |
| FISH cytogenetics, Döhner model (%) | ||||
| del(17p) | 12 (57) | 8 (62) | 11 (65) | 31 (61) |
| del(11q) | 2 (10) | 0 | 2 (12) | 4 (8) |
| Trisomy 12 | 0 | 0 | 1 (6) | 1 (2) |
| Normal | 4 (19) | 3 (23) | 2 (12) | 9 (18) |
| del(13q) | 3 (14) | 2 (15) | 1 (6) | 6 (12) |
| Molecular genetics (%) | ||||
| IGHV unmutated | 14 (67) | 9 (69) | 15 (88) | 38 (75) |
| TP53 mutated | 20 (95) | 12 (92) | 17 (100) | 49 (96) |
| NOTCH1 mutated | 2 (10) | 2 (15) | 2 (12) | 6 (12) |
| SF3B1 mutated | 4 (19) | 2 (15) | 3 (18) | 9 (18) |
| Complex karyotype, ≥3 aberrations (%) | 13 (68)* | NK* | 10 (59) | 23 (64)* |
| CLL-IPI (%) | ||||
| High | 3 (15) | 3 (23) | 5 (29) | 11 (22) |
| Very high risk | 17 (85) | 10 (77) | 12 (71) | 39 (78) |
CIRS, Cumulative Illness Rating Scale; CLL-IPI, International Prognostic Index for CLL; ECOG, Eastern Cooperative Oncology Group; NK, not known.
Missing patients: 2 in CLL2-BIO and all 13 in CLL2-BIG.