Baseline patient characteristics, BR-ibrutinib cohort (N = 30)
| Male, n (%) | 25 (83.3) |
| Median age, y (range) | 62 (41-82) |
| Median time from initial diagnosis to first dose, mo (range) | 78.6 (7.6-159.6) |
| ECOG performance status, n (%) | |
| 0 | 16 (53.3) |
| 1 | 14 (46.7) |
| Median number of prior treatment regimens for CLL/SLL | 2 |
| Number of prior regimens, n (%) | |
| 1 | 8 (26.7) |
| 2 | 9 (30.0) |
| 3 | 13 (43.3) |
| Prior therapies for CLL/SLL, n (%) | |
| Rituximab | 30 (100.0) |
| Purine analogs | 27 (90.0) |
| Cyclophosphamide | 24 (80.0) |
| Ofatumumab | 5 (16.7) |
| Bendamustine | 4 (13.3) |
| Alemtuzumab | 4 (13.3) |
| Anthracyclines | 2 (6.7) |
| Lenalidomide | 2 (6.7) |
| High-risk Rai stage (III-IV), n (%) | 16 (53.3) |
| Bulky disease (lymph nodes at least 5 cm), n (%) | 16 (53.3) |
| Presence of cytopenias at enrollment*, n (%) | |
| Neutropenia | 8 (26.7) |
| Anemia | 7 (23.3) |
| Thrombocytopenia | 14 (46.7) |
| FISH/cytogenetics,† n (%) | |
| Del 17p | 7 (23.3) |
| Del 11q | 10 (33.3) |
| Trisomy12 | 3 (10.0) |
| Del 13q (0-1 copy) | 7 (23.3) |
| Del 6q | 2 (6.7) |
| Median serum β2–microglobulin, mg/L (range) | 4.4 (1.7-15.3) |
| Median creatinine clearance, mL/min (range) | 89.0 (46.1-205.8) |
| Creatinine clearance <60 mL/min, n (%) | 4 (13.3) |
| Male, n (%) | 25 (83.3) |
| Median age, y (range) | 62 (41-82) |
| Median time from initial diagnosis to first dose, mo (range) | 78.6 (7.6-159.6) |
| ECOG performance status, n (%) | |
| 0 | 16 (53.3) |
| 1 | 14 (46.7) |
| Median number of prior treatment regimens for CLL/SLL | 2 |
| Number of prior regimens, n (%) | |
| 1 | 8 (26.7) |
| 2 | 9 (30.0) |
| 3 | 13 (43.3) |
| Prior therapies for CLL/SLL, n (%) | |
| Rituximab | 30 (100.0) |
| Purine analogs | 27 (90.0) |
| Cyclophosphamide | 24 (80.0) |
| Ofatumumab | 5 (16.7) |
| Bendamustine | 4 (13.3) |
| Alemtuzumab | 4 (13.3) |
| Anthracyclines | 2 (6.7) |
| Lenalidomide | 2 (6.7) |
| High-risk Rai stage (III-IV), n (%) | 16 (53.3) |
| Bulky disease (lymph nodes at least 5 cm), n (%) | 16 (53.3) |
| Presence of cytopenias at enrollment*, n (%) | |
| Neutropenia | 8 (26.7) |
| Anemia | 7 (23.3) |
| Thrombocytopenia | 14 (46.7) |
| FISH/cytogenetics,† n (%) | |
| Del 17p | 7 (23.3) |
| Del 11q | 10 (33.3) |
| Trisomy12 | 3 (10.0) |
| Del 13q (0-1 copy) | 7 (23.3) |
| Del 6q | 2 (6.7) |
| Median serum β2–microglobulin, mg/L (range) | 4.4 (1.7-15.3) |
| Median creatinine clearance, mL/min (range) | 89.0 (46.1-205.8) |
| Creatinine clearance <60 mL/min, n (%) | 4 (13.3) |
ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization.
Neutropenia was defined as baseline ANC ≤1500/μL, anemia was defined as baseline hemoglobin ≤11.0 g/dL, and thrombocytopenia was defined as baseline platelet count ≤100 000/μL.
Based on Dohner hierarchy for FISH cytogenetics.