Patient demographic and disease characteristics at baseline
| Characteristic . | Patients (n = 41) . |
|---|---|
| Median age, years (range) | 62.0 (35-85) |
| Age >65 y, n (%) | 14 (31.4) |
| Sex, n (%) | |
| Female | 17 (41.5) |
| Male | 24 (58.5) |
| Median time since first diagnosis, months (range) | 20.1 (1.1-131.6) |
| Binet stage, n (%) | |
| A | 9 (22.0) |
| B | 17 (41.5) |
| C | 15 (36.6) |
| Rai stage, n (%) | |
| 0 | 3 (7.3) |
| I | 14 (34.1) |
| II | 7 (17.1) |
| III | 11 (26.8) |
| IV | 6 (14.6) |
| B-symptoms, n (%) | |
| No | 26 (63.4) |
| Yes | 15 (36.6) |
| Median CIRS score (range) | 3 (0-8) |
| CIRS group, n (%) | |
| ≤6 | 39 (95.1) |
| >6 | 2 (4.9) |
| Median creatinine clearance, mL/min (range) | 81.1 (36.9-214.2) |
| Creatinine clearance <70 mL/min, n (%) | 15 (36.6) |
| del(17p)* and TP53 status, n (%) | |
| del(17p), TP53 mutated | 24 (58.5) |
| del(17p), TP53 unmutated | 2 (4.9) |
| No del(17p), TP53 mutated | 15 (36.6) |
| del(11q)*, n (%) | 5 (12.2) |
| del(13q)*, n (%) | 7 (17.1) |
| Trisomy 12*, n (%) | 2 (4.9) |
| IGHV mutational status, n (%) | |
| Unmutated | 32 (78.0) |
| Mutated | 6 (14.6) |
| Nonevaluable | 3 (7.3) |
| NOTCH1 status, n (%) | |
| Unmutated | 38 (92.7) |
| Mutated | 3 (7.3) |
| SF3B1 status, n (%) | |
| Unmutated | 34 (82.9) |
| Mutated | 7 (17.1) |
| Median IgG, g/L (range) | 7.5 (2.4-19.6) |
| Median IgA, g/L (range) | 0.8 (0.1-5.0) |
| Median IgM, g/L (range) | 0.4 (0.1-22.5) |
| Median IgE, g/L (range)† | 3.5 (0.3-401.1) |
| ECOG PS, n (%) | |
| 0 | 28 (68.3) |
| 1-2 | 13 (31.7) |
| TLS risk category at screening, n (%) | |
| Increased | 39 (95.1) |
| Not increased | 2 (4.9) |
| ALC at screening, n | 40 |
| Median | 65.7 |
| Range | 3.8-346.2 |
| TLS high risk: ALC >50 G/l at screening (according to protocol), n (%) | 23 (57.5) |
| TLS high risk: ALC >25 G/l at screening, n (%) | 31 (77.5) |
| Laboratory TLS (according to Cairo Bishop criteria), n | 4 |
| Urin acid (≥476 µmol/l or 25% increase from baseline), n | 2 |
| Potassium (≥6.0 mmol/l or 25% increase from baseline), n | 2 |
| Phosphorus (≥1.45 mmol/l or 25% increase from baseline), n | 4 |
| Calcium (<1.75 mmol/l or 25% increase from baseline),n | 0 |
| LDH (increased ≥25%), n | 1 |
| Serum Creatinine (increased ≥25%), n | 1 |
| Number of patients with hospitalization during dose ramp up of venetoclax, n (%) | 37 (90.2) |
| CLL-IPI risk group, n (%) | 39 |
| Low | 0 (0.0) |
| Intermediate | 0 (0.0) |
| High | 4 (10.3) |
| Very High | 35 (89.7) |
| Complex karyotype, n (%) | 39 |
| Noncomplex karyotype (<3 aberrations) | 15 (38.5) |
| Complex karyotype (≥3 aberrations) | 4 (10.3) |
| Highly complex karyotype (≥5 aberrations) | 20 (51.3) |
| Median serum β2-microglobulin, mg/dL (range)†† | 4.4 (2.5-12.5) |
| Median serum thymidine kinase, U/L (range)†† | 48.5 (9.6-300.0) |
| Characteristic . | Patients (n = 41) . |
|---|---|
| Median age, years (range) | 62.0 (35-85) |
| Age >65 y, n (%) | 14 (31.4) |
| Sex, n (%) | |
| Female | 17 (41.5) |
| Male | 24 (58.5) |
| Median time since first diagnosis, months (range) | 20.1 (1.1-131.6) |
| Binet stage, n (%) | |
| A | 9 (22.0) |
| B | 17 (41.5) |
| C | 15 (36.6) |
| Rai stage, n (%) | |
| 0 | 3 (7.3) |
| I | 14 (34.1) |
| II | 7 (17.1) |
| III | 11 (26.8) |
| IV | 6 (14.6) |
| B-symptoms, n (%) | |
| No | 26 (63.4) |
| Yes | 15 (36.6) |
| Median CIRS score (range) | 3 (0-8) |
| CIRS group, n (%) | |
| ≤6 | 39 (95.1) |
| >6 | 2 (4.9) |
| Median creatinine clearance, mL/min (range) | 81.1 (36.9-214.2) |
| Creatinine clearance <70 mL/min, n (%) | 15 (36.6) |
| del(17p)* and TP53 status, n (%) | |
| del(17p), TP53 mutated | 24 (58.5) |
| del(17p), TP53 unmutated | 2 (4.9) |
| No del(17p), TP53 mutated | 15 (36.6) |
| del(11q)*, n (%) | 5 (12.2) |
| del(13q)*, n (%) | 7 (17.1) |
| Trisomy 12*, n (%) | 2 (4.9) |
| IGHV mutational status, n (%) | |
| Unmutated | 32 (78.0) |
| Mutated | 6 (14.6) |
| Nonevaluable | 3 (7.3) |
| NOTCH1 status, n (%) | |
| Unmutated | 38 (92.7) |
| Mutated | 3 (7.3) |
| SF3B1 status, n (%) | |
| Unmutated | 34 (82.9) |
| Mutated | 7 (17.1) |
| Median IgG, g/L (range) | 7.5 (2.4-19.6) |
| Median IgA, g/L (range) | 0.8 (0.1-5.0) |
| Median IgM, g/L (range) | 0.4 (0.1-22.5) |
| Median IgE, g/L (range)† | 3.5 (0.3-401.1) |
| ECOG PS, n (%) | |
| 0 | 28 (68.3) |
| 1-2 | 13 (31.7) |
| TLS risk category at screening, n (%) | |
| Increased | 39 (95.1) |
| Not increased | 2 (4.9) |
| ALC at screening, n | 40 |
| Median | 65.7 |
| Range | 3.8-346.2 |
| TLS high risk: ALC >50 G/l at screening (according to protocol), n (%) | 23 (57.5) |
| TLS high risk: ALC >25 G/l at screening, n (%) | 31 (77.5) |
| Laboratory TLS (according to Cairo Bishop criteria), n | 4 |
| Urin acid (≥476 µmol/l or 25% increase from baseline), n | 2 |
| Potassium (≥6.0 mmol/l or 25% increase from baseline), n | 2 |
| Phosphorus (≥1.45 mmol/l or 25% increase from baseline), n | 4 |
| Calcium (<1.75 mmol/l or 25% increase from baseline),n | 0 |
| LDH (increased ≥25%), n | 1 |
| Serum Creatinine (increased ≥25%), n | 1 |
| Number of patients with hospitalization during dose ramp up of venetoclax, n (%) | 37 (90.2) |
| CLL-IPI risk group, n (%) | 39 |
| Low | 0 (0.0) |
| Intermediate | 0 (0.0) |
| High | 4 (10.3) |
| Very High | 35 (89.7) |
| Complex karyotype, n (%) | 39 |
| Noncomplex karyotype (<3 aberrations) | 15 (38.5) |
| Complex karyotype (≥3 aberrations) | 4 (10.3) |
| Highly complex karyotype (≥5 aberrations) | 20 (51.3) |
| Median serum β2-microglobulin, mg/dL (range)†† | 4.4 (2.5-12.5) |
| Median serum thymidine kinase, U/L (range)†† | 48.5 (9.6-300.0) |