Baseline patient characteristics
| Characteristic (n = 12) . | . |
|---|---|
| Age in years, median (range) | 57 (42-70) |
| Men, n (%) | 11 (92) |
| Number of prior therapies, median (range) | 1 (1-7) |
| IGHV unmutated, n (%) | 11 (92) |
| Zap-70 methylated*, n (%) | 5 (42) |
| Complex stimulated karyotype†, n (%) | 5 (42) |
| FISH panel‡, n (%) | |
| del(17)(p13.1) | 1 (8) |
| del(11)(q22.3) | 8 (67) |
| Trisomy 12 | 1 (8) |
| del(13)(q14) | 2 (17) |
| Baseline blood counts, median (range) | |
| White blood count, 1 × 109/L | 115.8 (8.5-469) |
| Absolute neutrophil count, 1 × 109/L | 5.1 (0-23.5) |
| Absolute lymphocyte count, 1 × 109/L | 107.2 (2.8-445.6) |
| Hemoglobin, g/dL | 12.4 (11.2-15.8) |
| Platelets, 1 × 109/L | 161 (102-227) |
| β-2 Microglobulin, mg/L, median (range) | 3.3 (2.2-6.8) |
| Creatinine, mg/dL, median (range) | 1.2 (0.7-1.4) |
| Bone marrow percent CLL§, median (range) | 74.3 (16-94.4) |
| Peripheral blood percent CLL§, median (range) | 81.1 (16-94.3) |
| Spleen palpable on exam, n (%) | 5 (50)|| |
| Maximum lymph node diameter on imaging, n (%) | |
| <5 cm | 6 (50) |
| ≥5 to <10 cm | 5 (42) |
| ≥10 cm | 1 (8) |
| TLS risk, n (%) | |
| Low | 1 (8) |
| Medium | 7 (58) |
| High | 4 (33) |
| Characteristic (n = 12) . | . |
|---|---|
| Age in years, median (range) | 57 (42-70) |
| Men, n (%) | 11 (92) |
| Number of prior therapies, median (range) | 1 (1-7) |
| IGHV unmutated, n (%) | 11 (92) |
| Zap-70 methylated*, n (%) | 5 (42) |
| Complex stimulated karyotype†, n (%) | 5 (42) |
| FISH panel‡, n (%) | |
| del(17)(p13.1) | 1 (8) |
| del(11)(q22.3) | 8 (67) |
| Trisomy 12 | 1 (8) |
| del(13)(q14) | 2 (17) |
| Baseline blood counts, median (range) | |
| White blood count, 1 × 109/L | 115.8 (8.5-469) |
| Absolute neutrophil count, 1 × 109/L | 5.1 (0-23.5) |
| Absolute lymphocyte count, 1 × 109/L | 107.2 (2.8-445.6) |
| Hemoglobin, g/dL | 12.4 (11.2-15.8) |
| Platelets, 1 × 109/L | 161 (102-227) |
| β-2 Microglobulin, mg/L, median (range) | 3.3 (2.2-6.8) |
| Creatinine, mg/dL, median (range) | 1.2 (0.7-1.4) |
| Bone marrow percent CLL§, median (range) | 74.3 (16-94.4) |
| Peripheral blood percent CLL§, median (range) | 81.1 (16-94.3) |
| Spleen palpable on exam, n (%) | 5 (50)|| |
| Maximum lymph node diameter on imaging, n (%) | |
| <5 cm | 6 (50) |
| ≥5 to <10 cm | 5 (42) |
| ≥10 cm | 1 (8) |
| TLS risk, n (%) | |
| Low | 1 (8) |
| Medium | 7 (58) |
| High | 4 (33) |
Baseline characteristics were assessed at study screening.
IGHV, immune globulin heavy chain gene; FISH, Fluorescence in situ hybridization; TLS, tumor lysis syndrome.
Methylated is >20% gene methylation.
Complex karyotype defined as ≥3 independent abnormalities.
Hierarchical by highest risk finding.
By flow cytometry.
Includes 10 patients, as 2 had previous splenectomy.