Baseline demographics and disease characteristics
| . | Phase 1, n = 13* . | Phase 2, n = 20 . |
|---|---|---|
| Demographics | ||
| Median age, y (range) | 64.0 (46-81) | 62.5 (36-81) |
| ≤70 y, n (%) | 9 (69) | 15 (75) |
| >70 y, n (%) | 4 (31) | 5 (25) |
| Male, n (%) | 9 (69) | 12 (60) |
| Disease characteristics | ||
| Median time from diagnosis, y (range) | 7.6 (2.6-15.2) | 8.7 (2.0-22.6) |
| Median no. of previous treatments, n (range) | 3 (1-8) | 3 (1-7) |
| Prior rituximab treatment, n (%) | 8 (62) | 10 (50) |
| Prior fludarabine treatment, n (%) | 13 (100) | 18 (90) |
| Rituximab refractory, n (%) | 0 (0) | 3 (15) |
| Screening assessment | ||
| Binet stage, n (%) | ||
| A | 5 (38) | 7/19 (37) |
| B | 6 (46) | 7/19 (37) |
| C | 1 (8) | 2/19 (11) |
| Unknown | 1 (8) | 3/19 (16) |
| Hematologic parameters | ||
| Median hemoglobin, g/dL (range) | 12.6 (9.4-14.9) | 12.2 (9.6-15.9) |
| Median platelets × 109 (range) | 191 (48-404) | 120 (38-246) |
| Median neutrophils × 109 (range) | 4.0 (1.3-8.6) | 2.6 (0-15) |
| Median lymphocytes × 109 (range) | 47.4 (7.0-119.3) | 58 (0.6-134.0) |
| Lymph nodes | ||
| ≥5 cm | 4 (31) | 7 (35) |
| ≥10 cm | 2 (15) | 1 (5) |
| Patients with splenomegaly, n (%) | 3 (23) | 8 (40) |
| Median SPD, mm2 (min-max) | 2124 (1068-26 732) | 3138 (330-6399) |
| . | Phase 1, n = 13* . | Phase 2, n = 20 . |
|---|---|---|
| Demographics | ||
| Median age, y (range) | 64.0 (46-81) | 62.5 (36-81) |
| ≤70 y, n (%) | 9 (69) | 15 (75) |
| >70 y, n (%) | 4 (31) | 5 (25) |
| Male, n (%) | 9 (69) | 12 (60) |
| Disease characteristics | ||
| Median time from diagnosis, y (range) | 7.6 (2.6-15.2) | 8.7 (2.0-22.6) |
| Median no. of previous treatments, n (range) | 3 (1-8) | 3 (1-7) |
| Prior rituximab treatment, n (%) | 8 (62) | 10 (50) |
| Prior fludarabine treatment, n (%) | 13 (100) | 18 (90) |
| Rituximab refractory, n (%) | 0 (0) | 3 (15) |
| Screening assessment | ||
| Binet stage, n (%) | ||
| A | 5 (38) | 7/19 (37) |
| B | 6 (46) | 7/19 (37) |
| C | 1 (8) | 2/19 (11) |
| Unknown | 1 (8) | 3/19 (16) |
| Hematologic parameters | ||
| Median hemoglobin, g/dL (range) | 12.6 (9.4-14.9) | 12.2 (9.6-15.9) |
| Median platelets × 109 (range) | 191 (48-404) | 120 (38-246) |
| Median neutrophils × 109 (range) | 4.0 (1.3-8.6) | 2.6 (0-15) |
| Median lymphocytes × 109 (range) | 47.4 (7.0-119.3) | 58 (0.6-134.0) |
| Lymph nodes | ||
| ≥5 cm | 4 (31) | 7 (35) |
| ≥10 cm | 2 (15) | 1 (5) |
| Patients with splenomegaly, n (%) | 3 (23) | 8 (40) |
| Median SPD, mm2 (min-max) | 2124 (1068-26 732) | 3138 (330-6399) |
SPD, sum of the products of the longest perpendicular dimensions of the six largest lymph nodes.
One patient in cohort 1200/2000 mg received 1600 mg as the first infusion instead of the assigned 1200 mg, therefore an extra patient was enrolled into the 1200/2000 mg cohort per protocol specifications, to confirm the safety and tolerability of the 1200/2000 mg dose in 3 patients.