Clinical characteristics of the patients at baseline
| Characteristic . | All patients (N = 37) . | Ibrutinib . | P . | |
|---|---|---|---|---|
| 420 mg (n = 24) . | 840 mg (n = 13) . | |||
| Median age at screening, y (range) | 64 (43-78) | 62 (43-77) | 69 (43-78) | .32 |
| Sex | .21 | |||
| Male | 30 (81.1) | 21 (87.5) | 9 (69.2) | |
| Female | 7 (18.9) | 3 (12.5) | 4 (30.8) | |
| No. of previous treatments (range) | 4 (0-12) | 4 (0-12) | 6 (0-8) | .54 |
| Splenectomy | 13 (35.1) | 6 (25.0) | 7 (53.9) | .15 |
| Median time from diagnosis, y (range) | 9.8 (0.2-42.1) | 9.7 (0.5-42.1) | 10.8 (0.2-34.6) | .71 |
| Histology | .04 | |||
| Classic | 28 (75.7) | 21 (87.5) | 7 (53.9) | |
| Variant | 9 (24.3) | 3 (12.5) | 6 (46.2) | |
| BRAF p.V600E status* | .17 | |||
| Positive | 20 (54.1) | 15 (62.5) | 5 (38.5) | |
| Negative | 16 (43.2) | 8 (33.3) | 8 (61.5) | |
| Unknown | 1 (2.7) | 1 (4.2) | 0 (0) | |
| Median laboratory values (range) | ||||
| Hemoglobin, g/dL | 12.4 (8.0-17.4) | 12.5 (8.0-15.6) | 10.7 (8.6-17.4) | .21 |
| Platelets × 103/μL | 93 (20-392) | 93 (35-392) | 108 (20-323) | .89 |
| WBC × 103/μL | 4.2 (0.9-105.3) | 2.3 (0.9-105.3) | 9.4 (1.3-60.5) | .10 |
| ANC × 103/μL | 1.50 (0.06-7.86) | 0.90 (0.45-5.17) | 2.68 (0.06-7.86) | .06 |
| ALC × 103/μL | 1.04 (0.20-11.13) | 0.71 (0.20-10.96) | 2.10 (0.30-11.13) | .01 |
| IgG, mg/dL | 755 (8.7-1617) | 755 (412-1617) | 844 (8.7-1359) | .68 |
| IgA, mg/dL | 92 (0.84-339) | 93.5 (7-339) | 52 (0.84-268) | .07 |
| IgM, mg/dL | 41 (0.44-470) | 42.5 (14-139) | 39 (0.44-470) | .44 |
| Characteristic . | All patients (N = 37) . | Ibrutinib . | P . | |
|---|---|---|---|---|
| 420 mg (n = 24) . | 840 mg (n = 13) . | |||
| Median age at screening, y (range) | 64 (43-78) | 62 (43-77) | 69 (43-78) | .32 |
| Sex | .21 | |||
| Male | 30 (81.1) | 21 (87.5) | 9 (69.2) | |
| Female | 7 (18.9) | 3 (12.5) | 4 (30.8) | |
| No. of previous treatments (range) | 4 (0-12) | 4 (0-12) | 6 (0-8) | .54 |
| Splenectomy | 13 (35.1) | 6 (25.0) | 7 (53.9) | .15 |
| Median time from diagnosis, y (range) | 9.8 (0.2-42.1) | 9.7 (0.5-42.1) | 10.8 (0.2-34.6) | .71 |
| Histology | .04 | |||
| Classic | 28 (75.7) | 21 (87.5) | 7 (53.9) | |
| Variant | 9 (24.3) | 3 (12.5) | 6 (46.2) | |
| BRAF p.V600E status* | .17 | |||
| Positive | 20 (54.1) | 15 (62.5) | 5 (38.5) | |
| Negative | 16 (43.2) | 8 (33.3) | 8 (61.5) | |
| Unknown | 1 (2.7) | 1 (4.2) | 0 (0) | |
| Median laboratory values (range) | ||||
| Hemoglobin, g/dL | 12.4 (8.0-17.4) | 12.5 (8.0-15.6) | 10.7 (8.6-17.4) | .21 |
| Platelets × 103/μL | 93 (20-392) | 93 (35-392) | 108 (20-323) | .89 |
| WBC × 103/μL | 4.2 (0.9-105.3) | 2.3 (0.9-105.3) | 9.4 (1.3-60.5) | .10 |
| ANC × 103/μL | 1.50 (0.06-7.86) | 0.90 (0.45-5.17) | 2.68 (0.06-7.86) | .06 |
| ALC × 103/μL | 1.04 (0.20-11.13) | 0.71 (0.20-10.96) | 2.10 (0.30-11.13) | .01 |
| IgG, mg/dL | 755 (8.7-1617) | 755 (412-1617) | 844 (8.7-1359) | .68 |
| IgA, mg/dL | 92 (0.84-339) | 93.5 (7-339) | 52 (0.84-268) | .07 |
| IgM, mg/dL | 41 (0.44-470) | 42.5 (14-139) | 39 (0.44-470) | .44 |
Data are presented as n (%) unless otherwise specified.
WBC, white blood cell count.
Details for method of BRAF testing are provided in supplemental Table 1.