Table 1.
Baseline Characteristics
| Dose Level 1 | Dose Level 2 | Total | |
|---|---|---|---|
| (Duvelisib 25 mg qd) | (Duvelisib 25 mg bid) | ||
| N=6 | N=26 | N=32 | |
| Median age (IQR), years | 55 (52–58) | 55 (52–59) | 55 (52–59) |
| Men, n (%) | 5 (83) | 17 (65) | 22 (69) |
| Women, n (%) | 1 (17) | 9 (35) | 10 (31) |
| ECOG performance status, n (%) | |||
| 0 | 2 (33) | 12 (46) | 14 (44) |
| 1 | 4 (67) | 14 (54) | 18 (56) |
| Rai stage, n (%) | |||
| 0 | 3 (50) | 4 (15) | 7 (22) |
| 1 | 2 (33) | 7 (27) | 9 (28) |
| 2 | 1 (17) | 2 (8) | 3 (9) |
| 3 | 0 (0) | 2 (8) | 2 (6) |
| 4 | 0 (0) | 11 (42) | 11 (34) |
| Median WBC (IQR), × 109/L | 79 (51–120) | 97 (20–182) | 97 (31–168) |
| Median hemoglobin (IQR), g/dL | 12 (11–14) | 10 (10–12) | 11 (10–13) |
| Median hematocrit (IQR), % | 37 (34–41) | 33 (29–39) | 34 (30–39) |
| Median platelets (IQR), × 109/L | 136 (89–180) | 110 (89–156) | 115 (88–157) |
| Median BM involvement (IQR), % | 90 (68–90) | 80 (70–90) | 80 (68–90) |
| Median IgG (IQR), mg/dL | 733 (632–794) | 835 (498–958) | 789 (527–955) |
| Median IgA (IQR), mg/dL | 73 (67–94) | 83 (64–145) | 79 (66–125) |
| Median β2-microglobulin (IQR), mg/L | 2.9 (2.875–3) | 4 (4–6) | 4 (4–6) |
| IGHV unmutated | 4/6 (67) | 14/26 (54) | 18/32 (56) |
| ZAP-70 positive | 2/6 (33) | 17/25 (68) | 19/31 (61) |
| Del(13q) | 2/6 (33) | 12/23 (52) | 14/29 (48) |
| Del(11q) | 2/6 (33) | 6/24 (25) | 8/30 (27) |
| Trisomy 12 | 1/66 (17) | 6/25 (24) | 7/31 (23) |
| Del(17p) | 0 (0) | 2/24 (8) | 2/30 (7) |
| 6q detected | 0 (0) | 3/13 (23) | 3/19 (16) |
| t(14:18) | 0 (0) | 1/14 (7) | 1/20 (5) |
| Normal FISH | 2/6 (33) | 4/26 (15) | 6/32 (19) |
| TP53 mutation | 0 (0) | 4/26 (15) | 4/32 (13) |
| NOTCH1 mutation | 0 (0) | 1/26 (4) | 1/32 (3) |
| MYD88 mutation | 0 (0) | 1/24 (4) | 1/24 (4) |