Baseline demographics and disease characteristics (intent-to-treat population)
| Characteristic . | HCL (N = 55) . |
|---|---|
| Age, median (range), y | 66.0 (40-89) |
| Male sex, n (%) | 47 (85.5) |
| Race, n (%) | |
| White–European/Caucasian | 48 (87.3) |
| White–Arabic or North African | 1 (1.8) |
| Missing | 6 (10.9) |
| ECOG PS, n (%) | |
| 0 | 28 (50.9) |
| 1 | 26 (47.3) |
| 2 | 1 (1.8) |
| Central BRAF V600E mutation status, n (%) | |
| Positive | 50 (90.9) |
| Negative | 4 (7.3) |
| Missing | 1 (1.8) |
| Time since diagnosis, median (range), y | 12.5 (0.2-33.2) |
| Number of prior treatment regimens, n (%) | |
| 1 | 2 (3.6) |
| 2 | 9 (16.4) |
| 3 | 16 (29.1) |
| ≥4 | 28 (50.9) |
| Prior treatment regimen, n (%)∗ | |
| Cladribine | 52 (94.5) |
| Rituximab | 35 (63.6) |
| Pentostatin | 13 (23.6) |
| Interferon | 12 (21.8) |
| Moxetumomab pasudotox | 11 (20.0) |
| Cladribine + rituximab | 6 (10.9) |
| Pentostatin + rituximab | 4 (7.3) |
| Investigational drug | 4 (7.3) |
| Bendamustine + rituximab | 3 (5.5) |
| Interferon alfa | 2 (3.6) |
| Peginterferon alfa-2a | 2 (3.6) |
| Dexamethasone + pentostatin | 1 (1.8) |
| Fludarabine + rituximab | 1 (1.8) |
| Rituximab + sargramostim | 1 (1.8) |
| Ibrutinib | 1 (1.8) |
| Ruxolitinib phosphate | 1 (1.8) |
| Ofatumumab | 1 (1.8) |
| Sargramostim | 1 (1.8) |
| Methotrexate | 1 (1.8) |
| Blood counts, median (range) | |
| Hemoglobin, g/L | 98.0 (57.0-175.0) |
| Neutrophils, × 109/L | 0.8 (0.1-4.6) |
| Platelets, × 109/L | 70.0 (5.0-179.0) |
| Spleen size, mm, median (interquartile range)† | |
| CT scan, n = 29 | 150.0 (130.0-203.0) |
| Direct physical examination, n = 21 | 150.0 (130.0-202.0) |
| Ultrasound, n = 4 | 153.0 (131.0-167.5) |
| MRI, n = 2 | 155.0 (150.0-160.0) |
| Characteristic . | HCL (N = 55) . |
|---|---|
| Age, median (range), y | 66.0 (40-89) |
| Male sex, n (%) | 47 (85.5) |
| Race, n (%) | |
| White–European/Caucasian | 48 (87.3) |
| White–Arabic or North African | 1 (1.8) |
| Missing | 6 (10.9) |
| ECOG PS, n (%) | |
| 0 | 28 (50.9) |
| 1 | 26 (47.3) |
| 2 | 1 (1.8) |
| Central BRAF V600E mutation status, n (%) | |
| Positive | 50 (90.9) |
| Negative | 4 (7.3) |
| Missing | 1 (1.8) |
| Time since diagnosis, median (range), y | 12.5 (0.2-33.2) |
| Number of prior treatment regimens, n (%) | |
| 1 | 2 (3.6) |
| 2 | 9 (16.4) |
| 3 | 16 (29.1) |
| ≥4 | 28 (50.9) |
| Prior treatment regimen, n (%)∗ | |
| Cladribine | 52 (94.5) |
| Rituximab | 35 (63.6) |
| Pentostatin | 13 (23.6) |
| Interferon | 12 (21.8) |
| Moxetumomab pasudotox | 11 (20.0) |
| Cladribine + rituximab | 6 (10.9) |
| Pentostatin + rituximab | 4 (7.3) |
| Investigational drug | 4 (7.3) |
| Bendamustine + rituximab | 3 (5.5) |
| Interferon alfa | 2 (3.6) |
| Peginterferon alfa-2a | 2 (3.6) |
| Dexamethasone + pentostatin | 1 (1.8) |
| Fludarabine + rituximab | 1 (1.8) |
| Rituximab + sargramostim | 1 (1.8) |
| Ibrutinib | 1 (1.8) |
| Ruxolitinib phosphate | 1 (1.8) |
| Ofatumumab | 1 (1.8) |
| Sargramostim | 1 (1.8) |
| Methotrexate | 1 (1.8) |
| Blood counts, median (range) | |
| Hemoglobin, g/L | 98.0 (57.0-175.0) |
| Neutrophils, × 109/L | 0.8 (0.1-4.6) |
| Platelets, × 109/L | 70.0 (5.0-179.0) |
| Spleen size, mm, median (interquartile range)† | |
| CT scan, n = 29 | 150.0 (130.0-203.0) |
| Direct physical examination, n = 21 | 150.0 (130.0-202.0) |
| Ultrasound, n = 4 | 153.0 (131.0-167.5) |
| MRI, n = 2 | 155.0 (150.0-160.0) |
CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; MRI, magnetic resonance imaging.
Patients may have had more than 1 prior therapy.
Patients may have had spleen size assessments by more than 1 method. Physical examination could estimate spleen size by palpation below and percussion above the left costal margin.