Demographics and baseline characteristics
| Characteristic . | Dose escalation (n = 57) . | Dose expansion (n = 26) . | ||
|---|---|---|---|---|
| No. . | % . | No. . | % . | |
| Sex | ||||
| Female | 20 | 35.1 | 12 | 46.2 |
| Male | 37 | 64.9 | 14 | 53.8 |
| Age | ||||
| Median | 66 | 69 | ||
| Range | 44-83 | 39-81 | ||
| ≥70 y | 21 | 36.8 | 12 | 46.2 |
| β2-microgobulin, mg/L | ||||
| 0-3 | 12 | 21.1 | 16 | 61.5 |
| 3.1-5 | 21 | 36.8 | 6 | 23.1 |
| 5.1-10 | 19 | 33.3 | 2 | 7.7 |
| >10 | 4 | 7.0 | 0 | |
| Unknown | 1 | 1.8 | 2 | 7.7 |
| ANC <1.5 × 109/L | 15 | 26.3 | 10 | 38.5 |
| Hemoglobin ≤11 g/dL | 32 | 56.1 | 13 | 50.0 |
| Platelets <100 000 × 109/L | 26 | 45.6 | 6 | 23.1 |
| Rai stage | ||||
| 0 | 1 | 1.8 | 3 | 11.5 |
| 1-2 | 17 | 29.8 | 11 | 42.3 |
| 3-4 | 39 | 68.4 | 11 | 42.3 |
| Not recorded | — | 1 | 3.8 | |
| Duration since diagnosis, y | ||||
| Median | 7 | 7 | ||
| Range | 1-21 | 0-33 | ||
| Time since last treatment, mo | ||||
| N/A | 7 | 26.9 | ||
| <6 | 25 | 43.9 | 7 | 26.9 |
| 6-12 | 14 | 24.6 | 1 | 3.8 |
| >12 | 18 | 31.6 | 11 | 42.3 |
| Any one lymph node >5 cm | 27 | 47.4 | 6 | 23.2 |
| Hepatomegaly | 2 | 3.5 | 1 | 3.8 |
| Splenomegaly | 13 | 22.8 | 7 | 26.9 |
| B symptoms | 25 | 78* | 17 | 65.4 |
| SLL | 6 | 10.5 | 0 | |
| ECOG PS | ||||
| 0 | 18 | 31.6 | 13 | 50.0 |
| 1 | 36 | 63.2 | 13 | 50.0 |
| 2 | 3 | 5.3 | 0 | |
| No. of previous therapies | ||||
| Median | 4 | 1 | ||
| Range | 1-13 | 0-11 | ||
| 0 | 0 | 7 | 26.9 | |
| 1-2 | 17 | 29.8 | 11 | 42.3 |
| 3-6 | 23 | 40.3 | 5 | 19.2 |
| 7-10 | 12 | 21.1 | 2 | 0.8 |
| >10 | 5 | 8.8 | 1 | 3.8 |
| Previous anti-CD20 therapy | ||||
| Median | 2 | 1 | ||
| Range | 0-7 | 0-9 | ||
| 0 | 5 | 8.8 | 12 | 46.2 |
| 1-2 | 31 | 54.3 | 8 | 30.8 |
| 3 | 8 | 14.0 | 3 | 11.5 |
| 4 | 5 | 8.8 | 0 | |
| ≥5 | 8 | 14.0 | 3 | 11.5 |
| FISH | ||||
| 17p | 23 | 2 | ||
| 13q | 29 | 10 | ||
| 11q | 14 | 3 | ||
| Characteristic . | Dose escalation (n = 57) . | Dose expansion (n = 26) . | ||
|---|---|---|---|---|
| No. . | % . | No. . | % . | |
| Sex | ||||
| Female | 20 | 35.1 | 12 | 46.2 |
| Male | 37 | 64.9 | 14 | 53.8 |
| Age | ||||
| Median | 66 | 69 | ||
| Range | 44-83 | 39-81 | ||
| ≥70 y | 21 | 36.8 | 12 | 46.2 |
| β2-microgobulin, mg/L | ||||
| 0-3 | 12 | 21.1 | 16 | 61.5 |
| 3.1-5 | 21 | 36.8 | 6 | 23.1 |
| 5.1-10 | 19 | 33.3 | 2 | 7.7 |
| >10 | 4 | 7.0 | 0 | |
| Unknown | 1 | 1.8 | 2 | 7.7 |
| ANC <1.5 × 109/L | 15 | 26.3 | 10 | 38.5 |
| Hemoglobin ≤11 g/dL | 32 | 56.1 | 13 | 50.0 |
| Platelets <100 000 × 109/L | 26 | 45.6 | 6 | 23.1 |
| Rai stage | ||||
| 0 | 1 | 1.8 | 3 | 11.5 |
| 1-2 | 17 | 29.8 | 11 | 42.3 |
| 3-4 | 39 | 68.4 | 11 | 42.3 |
| Not recorded | — | 1 | 3.8 | |
| Duration since diagnosis, y | ||||
| Median | 7 | 7 | ||
| Range | 1-21 | 0-33 | ||
| Time since last treatment, mo | ||||
| N/A | 7 | 26.9 | ||
| <6 | 25 | 43.9 | 7 | 26.9 |
| 6-12 | 14 | 24.6 | 1 | 3.8 |
| >12 | 18 | 31.6 | 11 | 42.3 |
| Any one lymph node >5 cm | 27 | 47.4 | 6 | 23.2 |
| Hepatomegaly | 2 | 3.5 | 1 | 3.8 |
| Splenomegaly | 13 | 22.8 | 7 | 26.9 |
| B symptoms | 25 | 78* | 17 | 65.4 |
| SLL | 6 | 10.5 | 0 | |
| ECOG PS | ||||
| 0 | 18 | 31.6 | 13 | 50.0 |
| 1 | 36 | 63.2 | 13 | 50.0 |
| 2 | 3 | 5.3 | 0 | |
| No. of previous therapies | ||||
| Median | 4 | 1 | ||
| Range | 1-13 | 0-11 | ||
| 0 | 0 | 7 | 26.9 | |
| 1-2 | 17 | 29.8 | 11 | 42.3 |
| 3-6 | 23 | 40.3 | 5 | 19.2 |
| 7-10 | 12 | 21.1 | 2 | 0.8 |
| >10 | 5 | 8.8 | 1 | 3.8 |
| Previous anti-CD20 therapy | ||||
| Median | 2 | 1 | ||
| Range | 0-7 | 0-9 | ||
| 0 | 5 | 8.8 | 12 | 46.2 |
| 1-2 | 31 | 54.3 | 8 | 30.8 |
| 3 | 8 | 14.0 | 3 | 11.5 |
| 4 | 5 | 8.8 | 0 | |
| ≥5 | 8 | 14.0 | 3 | 11.5 |
| FISH | ||||
| 17p | 23 | 2 | ||
| 13q | 29 | 10 | ||
| 11q | 14 | 3 | ||
ECOG PS, Eastern Cooperative Oncology Group performance score; FISH, fluorescence in situ hybridization; N/A, not applicable; SLL, small lymphocytic leukemia.
B symptoms were not collected in cohorts 1 through 7; symptoms were collected for 32 patients.