Baseline demographic and clinical characteristics
| . | Group 1: ibrutinib → ofatumumab (N = 27) . | Group 2: ibrutinib/ofatumumab (N = 20) . | Group 3: ofatumumab → ibrutinib (N = 24) . | All patients (N = 71) . |
|---|---|---|---|---|
| Median age (range), years | 66 (51-85) | 63 (48-75) | 63 (50-71) | 64 (48-85) |
| ≥65 years | 14 (52) | 8 (40) | 9 (38) | 31 (44) |
| ≥70 years | 12 (44) | 4 (20) | 1 (4) | 17 (24) |
| Diagnosis, n (%) | ||||
| CLL | 22 (82) | 19 (95) | 24 (100) | 65 (92) |
| SLL | 1 (4) | 0 (0) | 0 (0) | 1 (1) |
| PLL | 1 (4) | 1 (5) | 0 (0) | 2 (3) |
| Richter’s transformation | 3 (11) | 0 (0) | 0 (0) | 3 (4) |
| ECOG performance status, n (%) | ||||
| 0 | 10 (37) | 8 (40) | 5 (21) | 23 (32) |
| 1 | 16 (59) | 11 (55) | 15 (63) | 42 (59) |
| 2 | 1 (4) | 1 (5) | 4 (17) | 6 (9) |
| Bulky disease, n (%) | ||||
| Lymph nodes ≥5 cm | 19 (70) | 13 (65) | 21 (88) | 53 (75) |
| Lymph nodes ≥10 cm | 3 (11) | 3 (15) | 5 (21) | 11 (16) |
| Rai risk classification,*n (%) | ||||
| Low risk | 1 (4) | 0 (0) | 1 (4) | 2 (3) |
| Intermediate risk | 11 (41) | 5 (25) | 8 (33) | 24 (34) |
| High risk | 14 (52) | 14 (70) | 15 (63) | 43 (61) |
| Not reported | 1 (4) | 1 (5) | (0) | 2 (3) |
| Cytopenia at baseline, n (%) | ||||
| ANC ≤1500/µL | 5 (19) | 6 (30) | 9 (38) | 20 (28) |
| Hemoglobin ≤11 g/dL | 11 (41) | 12 (60) | 10 (42) | 33 (47) |
| Platelets ≤100 000/µL | 13 (48) | 12 (60) | 11 (46) | 36 (51) |
| Prognostic factors, n (%) | ||||
| Unmutated IGHV | 20 (74) | 13 (65) | 17 (71) | 50 (70) |
| Del17(17)(p13.1) | 10 (37) | 9 (45) | 12 (50) | 31 (44) |
| Del(11)(q22.3) | 9 (33) | 6 (30) | 7 (29) | 22 (31) |
| β2-Microglobulin >3 mg/L | 15 (56) | 12 (60) | 13 (54) | 40 (56) |
| . | Group 1: ibrutinib → ofatumumab (N = 27) . | Group 2: ibrutinib/ofatumumab (N = 20) . | Group 3: ofatumumab → ibrutinib (N = 24) . | All patients (N = 71) . |
|---|---|---|---|---|
| Median age (range), years | 66 (51-85) | 63 (48-75) | 63 (50-71) | 64 (48-85) |
| ≥65 years | 14 (52) | 8 (40) | 9 (38) | 31 (44) |
| ≥70 years | 12 (44) | 4 (20) | 1 (4) | 17 (24) |
| Diagnosis, n (%) | ||||
| CLL | 22 (82) | 19 (95) | 24 (100) | 65 (92) |
| SLL | 1 (4) | 0 (0) | 0 (0) | 1 (1) |
| PLL | 1 (4) | 1 (5) | 0 (0) | 2 (3) |
| Richter’s transformation | 3 (11) | 0 (0) | 0 (0) | 3 (4) |
| ECOG performance status, n (%) | ||||
| 0 | 10 (37) | 8 (40) | 5 (21) | 23 (32) |
| 1 | 16 (59) | 11 (55) | 15 (63) | 42 (59) |
| 2 | 1 (4) | 1 (5) | 4 (17) | 6 (9) |
| Bulky disease, n (%) | ||||
| Lymph nodes ≥5 cm | 19 (70) | 13 (65) | 21 (88) | 53 (75) |
| Lymph nodes ≥10 cm | 3 (11) | 3 (15) | 5 (21) | 11 (16) |
| Rai risk classification,*n (%) | ||||
| Low risk | 1 (4) | 0 (0) | 1 (4) | 2 (3) |
| Intermediate risk | 11 (41) | 5 (25) | 8 (33) | 24 (34) |
| High risk | 14 (52) | 14 (70) | 15 (63) | 43 (61) |
| Not reported | 1 (4) | 1 (5) | (0) | 2 (3) |
| Cytopenia at baseline, n (%) | ||||
| ANC ≤1500/µL | 5 (19) | 6 (30) | 9 (38) | 20 (28) |
| Hemoglobin ≤11 g/dL | 11 (41) | 12 (60) | 10 (42) | 33 (47) |
| Platelets ≤100 000/µL | 13 (48) | 12 (60) | 11 (46) | 36 (51) |
| Prognostic factors, n (%) | ||||
| Unmutated IGHV | 20 (74) | 13 (65) | 17 (71) | 50 (70) |
| Del17(17)(p13.1) | 10 (37) | 9 (45) | 12 (50) | 31 (44) |
| Del(11)(q22.3) | 9 (33) | 6 (30) | 7 (29) | 22 (31) |
| β2-Microglobulin >3 mg/L | 15 (56) | 12 (60) | 13 (54) | 40 (56) |
ECOG, Eastern Cooperative Oncology Group.
Low risk, stage 0; intermediate risk, stage I or II; high risk, stage III or IV.