Table 1.
Characteristics of the subjects with CLL at baseline and study status (N = 41)
| Characteristic | |
|---|---|
| Median age (range), year | 73 (51-89) |
| Rai stage (% of subjects) | |
| 0 | 3 (7.3%) |
| 1 or 2 | 18 (43.9%) |
| 3 or 4 | 20 (48.8%) |
| Extent of CLL (% of subjects) | |
| Anemia | |
| Any grade | 21 (51.2%) |
| Grade ≥ 3 | 0 |
| Neutropenia | |
| Any grade | 14 (34.1%) |
| Grade ≥ 3 | 2 (4.9%) |
| Thrombocytopenia | |
| Any grade | 22 (53.7%) |
| Grade ≥ 3 | 1 (2.4%) |
| Median ALC (range), mm3 | 30 070 (740-222 200) |
| Median estimated creatinine clearance (range), mL/minute | 63.8 (25.2-123.6) |
| Genetic risk factors from high to low risk (% of subjects) | |
| 17p deletion or TP53 mutation | 10 (24.4%) |
| 11q deletion | 10 (24.4%) |
| NOTCH1 or SF3B1 mutation | 7 (17.1%) |
| None of the above mutations or deletions | 12 (29.3%) |
| Undetermined | 2 (4.9%) |
| IGHV status | |
| Mutated | 8 (19.5%) |
| Unmutated | 31 (75.6%) |
| Undetermined | 2 (4.9%) |
| Previous CLL treatment | |
| Median number of regimens (range) | 2 (1-8) |
| Drugs (% of subjects) | |
| Anti-CD20 agents | 40 (97.6%) |
| Rituximab | 39 (95.1%) |
| Ofatumumab | 5 (12.2%) |
| Alkylating agents | 35 (85.4%) |
| Bendamustine | 26 (63.4%) |
| Fludarabine | 28 (68.3%) |
| Study status (%) | |
| Treated | 41 |
| Continued study drug | 16 (39.0%) |
| Discontinued study drug | 25 (61.0%) |
| Adverse events | 4 (8.8%) |
| Progressive disease | 16 (39.0%) |
| Death | 1 (2.4%) |
| Investigator decision | 3 (7.3%) |
| Withdrawn consent | 1 (2.4%) |
| Discontinued study | 25 (61%) |
ALC, absolute lymphocyte count; IGHV, immunoglobulin heavy chain variable.