Table 1.
Patient baseline characteristics (N = 13)*
| Demographic and baseline characteristics | Total |
|---|---|
| Sex | |
| Male | 8 (61.5) |
| Female | 5 (38.5) |
| Age (y) | |
| Median (range) | 75.0 (59–88) |
| ≥70 | 11 (84.6) |
| Binet stage | |
| A | 2 (15.4) |
| B | 3 (23.1) |
| C | 8 (61.5) |
| CIRS score (total) | |
| Median (range) | 8 (6–14) |
| >6 | 10 (76.9) |
| Cardiac scale score >0 | 6 (46.2) |
| Hypertension scale score >0 | 7 (53.8) |
| Vascular scale score >0 | 7 (53.8) |
| Respiratory scale score >0 | 9 (69.2) |
| Eye, ear, nose, throat, larynx scale score >0 | 6 (46.2) |
| Upper gastrointestinal scale score >0 | 4 (30.8) |
| Lower gastrointestinal scale score >0 | 5 (38.5) |
| Hepatic scale score >0 | 1 (7.7) |
| Renal scale score >0 | 5 (38.5) |
| Other genitourinary scale score >0 | 7 (53.8) |
| Musculoskeletal-integumentary scale score >0 | 8 (61.5) |
| Neurological scale score >0 | 3 (23.1) |
| Endocrine-metabolic scale score >0 | 8 (61.5) |
| Psychiatric-behavioral scale score >0 | 2 (15.4) |
| CrCl* (mL/min) | |
| Median (range) | 57.6 (30.3-108.2) |
| <70 | 10 (76.9) |
| Cytogenetic subgroup (hierarchical order) (n = 8) | |
| del(17p) | 2 (25.0) |
| del(11q) | 2 (25.0) |
| Trisomy 12 | 1 (12.5) |
| Not del(17p)/del(11q)/trisomy 12/del(13q) | 0 (0.0) |
| del(13q) | 3 (37.5) |
| Missing sample | 5 (41.7) |
| TP53 mutational status (n = 8) | |
| Mutated | 2 (25.0) |
| Not mutated | 6 (75.0) |
| Missing sample | 5 (41.7) |
| TP53 deleted and/or mutated (n = 8) | |
| Yes | 2 (25.0) |
| None | 6 (75.0) |
| Missing sample | 5 (41.7) |
| IGHV mutational status (n = 7) | |
| Mutated | 1 (14.3) |
| Unmutated | 6 (85.7) |
| Missing sample | 5 (41.7) |
| Sample not evaluable | 1 (7.7) |
Values represent number (percentage) of patients unless otherwise indicated.
CrCl, creatinine clearance.
*
One patient developed a grade 4 IRR during the first dose of obinutuzumab and was withdrawn from the study according to protocol requirements.