Table I.
Patient demographics and disease characteristics.
| Characteristic | Arm A: rituximab (n = 40) | Arm B: rituximab + ABT-263 (n = 38) | Arm C: rituximab + ABT-263 to PD (n = 40) | Total (n = 118) |
|---|---|---|---|---|
| Age in years, median (range) | 65 (48-94) | 62 (41-82) | 63 (38-80) | 63 (38-94) |
| Sex, n (%) | ||||
| Male | 23 (58) | 24 (63) | 27 (68) | 74 (63) |
| Female | 17 (42) | 14 (37) | 13 (32) | 44 (37) |
| Race, n (%) | ||||
| White | 39 (98) | 37 (97) | 39 (98) | 115 (97) |
| Country | ||||
| Australia | 10 (25) | 6 (16) | 3 (8) | 19 (16) |
| Brazil | 0 (0) | 0 (0) | 3 (8) | 3 (3) |
| France | 1 (3) | 0 (0) | 0 (0) | 1 (1) |
| Israel | 1 (3) | 0 (0) | 2 (5) | 3 (3) |
| Italy | 0 (0) | 0 (0) | 1 (3) | 1 (1) |
| Poland | 1 (3) | 3 (8) | 6 (15) | 10 (8) |
| Russia | 0 (0) | 2 (5) | 0 (0) | 2 (2) |
| Ukraine | 13 (33) | 14 (37) | 14 (35) | 41 (35) |
| United States | 14 (35) | 13 (34) | 11 (28) | 38 (32) |
| ECOG status ≤ 1, n (%) | 37 (93) | 36 (95) | 39 (98) | 112 (95) |
| Binet stage, n (%) | ||||
| A | 22 (55) | 16 (42) | 15 (38) | 53 (45) |
| B | 15 (38) | 16 (42) | 21 (53) | 52 (44) |
| C | 3 (8) | 6 (16) | 4 (10) | 13 (11) |
| Lymphocytes × 1000/mm3, median (range) | 47 (7-283) | 84 (10-347) | 54 (7-552) | 53 (7-552) |
| Prognostic features | ||||
| Unmutated IgVH | 13 (33) | 8 (21) | 16 (40) | 37 (31) |
| FISH: del(17p) | 11 (28) | 12 (32) | 10 (25) | 33 (28) |
| FISH: del(11q) | 11 (28) | 11 (29) | 15 (38) | 37 (31) |
| FISH: + 12 | 8 (20) | 5 (13) | 6 (15) | 19 (16) |
| FISH: del(13q) | 21 (53) | 22 (58) | 21 (53) | 64 (54) |
| CD38 (≥ 30%) | 9 (23) | 15 (39) | 11 (28) | 35 (30) |
| β2-Microglobulin elevated > 2 × nl | 29 (73) | 34 (89) | 33 (83) | 96 (81) |
ECOG, Eastern Cooperative Oncology Group; IgVH, immunoglobulin heavy chain variable gene; FISH, fluorescence in situ hybridization; nl, normal; PD, progressive disease.