Baseline pretreatment patient characteristics (ITT population)
| Characteristic . | Ibrutinib (n = 195) . | Ofatumumab (n = 196) . |
|---|---|---|
| Age, y | ||
| Median (range) | 67 (30-86) | 67 (37-88) |
| ≥70 | 78 (40) | 80 (41) |
| Male sex | 129 (66) | 137 (70) |
| Time since initial diagnosis, median (range), mo | 92 (5-329) | 91 (6-346) |
| Histology at diagnosis | ||
| CLL | 185 (95) | 188 (96) |
| SLL | 10 (5) | 8 (4) |
| Rai stage at screening | ||
| 0 | 5 (3) | 2 (1) |
| I | 51 (26) | 42 (21) |
| II | 30 (15) | 39 (20) |
| III | 23 (12) | 35 (18) |
| IV | 86 (44) | 78 (40) |
| ECOG PS | ||
| 0 | 79 (41) | 80 (41) |
| 1 | 116 (59) | 116 (59) |
| Bulky disease (lymph node ≥5 cm) | 124 (64) | 101 (52) |
| LDH, U/L | ||
| Median (range) | 232 (40-1937) | 228 (94-1301) |
| B2M, mg/L | ||
| Median (range) | 5.8 (1.8-20.2) | 5.8 (2.0-17.1) |
| ≤3.5 | 30 (15) | 28 (14) |
| >3.5 | 153 (78) | 145 (74) |
| Number of prior therapies | ||
| Median (range) | 3 (1-12) | 2 (1-13) |
| 1 | 35 (18) | 53 (27) |
| 2 | 57 (29) | 53 (27) |
| ≥3 | 103 (53) | 90 (46) |
| Genomic abnormalities | ||
| del(17p)(13.1) | 63/195 (32) | 64/196 (33) |
| del(11q)(22.3) | 63/190 (33) | 59/191 (31) |
| Complex karyotype* | 39/153 (25) | 33/147 (22) |
| IGHV unmutated† | 98/134 (73) | 84/133 (63) |
| NOTCH1 mutation‡ | 43/154 (28) | 45/149 (30) |
| TP53 mutation‡ | 79/154 (51) | 68/149 (46) |
| SF3B1 mutation‡ | 47/154 (31) | 44/149 (30) |
| BIRC3 mutation‡ | 21/154 (14) | 15/149 (10) |
| XPO1 mutation‡ | 26/154 (17) | 12/149 (8) |
| CLL-IPI risk group§ | ||
| Low risk | 1 (<1) | 1 (<1) |
| Intermediate risk | 10 (5) | 15 (8) |
| High risk | 46 (24) | 53 (27) |
| Very high risk | 70 (36) | 49 (25) |
| Missing | 68 (35) | 78 (40) |
| Characteristic . | Ibrutinib (n = 195) . | Ofatumumab (n = 196) . |
|---|---|---|
| Age, y | ||
| Median (range) | 67 (30-86) | 67 (37-88) |
| ≥70 | 78 (40) | 80 (41) |
| Male sex | 129 (66) | 137 (70) |
| Time since initial diagnosis, median (range), mo | 92 (5-329) | 91 (6-346) |
| Histology at diagnosis | ||
| CLL | 185 (95) | 188 (96) |
| SLL | 10 (5) | 8 (4) |
| Rai stage at screening | ||
| 0 | 5 (3) | 2 (1) |
| I | 51 (26) | 42 (21) |
| II | 30 (15) | 39 (20) |
| III | 23 (12) | 35 (18) |
| IV | 86 (44) | 78 (40) |
| ECOG PS | ||
| 0 | 79 (41) | 80 (41) |
| 1 | 116 (59) | 116 (59) |
| Bulky disease (lymph node ≥5 cm) | 124 (64) | 101 (52) |
| LDH, U/L | ||
| Median (range) | 232 (40-1937) | 228 (94-1301) |
| B2M, mg/L | ||
| Median (range) | 5.8 (1.8-20.2) | 5.8 (2.0-17.1) |
| ≤3.5 | 30 (15) | 28 (14) |
| >3.5 | 153 (78) | 145 (74) |
| Number of prior therapies | ||
| Median (range) | 3 (1-12) | 2 (1-13) |
| 1 | 35 (18) | 53 (27) |
| 2 | 57 (29) | 53 (27) |
| ≥3 | 103 (53) | 90 (46) |
| Genomic abnormalities | ||
| del(17p)(13.1) | 63/195 (32) | 64/196 (33) |
| del(11q)(22.3) | 63/190 (33) | 59/191 (31) |
| Complex karyotype* | 39/153 (25) | 33/147 (22) |
| IGHV unmutated† | 98/134 (73) | 84/133 (63) |
| NOTCH1 mutation‡ | 43/154 (28) | 45/149 (30) |
| TP53 mutation‡ | 79/154 (51) | 68/149 (46) |
| SF3B1 mutation‡ | 47/154 (31) | 44/149 (30) |
| BIRC3 mutation‡ | 21/154 (14) | 15/149 (10) |
| XPO1 mutation‡ | 26/154 (17) | 12/149 (8) |
| CLL-IPI risk group§ | ||
| Low risk | 1 (<1) | 1 (<1) |
| Intermediate risk | 10 (5) | 15 (8) |
| High risk | 46 (24) | 53 (27) |
| Very high risk | 70 (36) | 49 (25) |
| Missing | 68 (35) | 78 (40) |
Data are presented as n (%) of patients.
B2M, β-2 microglobulin; CLL-IPI, Chronic Lymphocytic Leukemia International Prognostic Index; LDH, lactate dehydrogenase; PS, performance status.
Complex karyotype data were reported by the investigator; data were not available for 42 patients in the ibrutinib arm and 49 patients in ofatumumab arm. Complex karyotype was defined as ≥3 cytogenetic abnormalities based on karyotyping (conventional cytogenetics) by local laboratories and did not require routine stimulation.
IGHV mutation status was assessed by a central laboratory; data were not available for 61 patients in ibrutinib arm and 63 patients in ofatumumab arm.
Data were not available for 41 patients in the ibrutinib arm and 47 patients in the ofatumumab arm.
CLL-IPI risk group was determined for patients with data available for all 5 variables (age, clinical stage, del(17p)(13.1) and/or TP53 mutation status, IGHV mutation status, and B2M level); for patients with known del(17p)(13.1) status but unknown (missing) TP53 mutation status, grading for this variable was determined based on del(17p)(13.1) status.