Table 1.
Demographics and baseline characteristics
| Characteristic | All patients (n = 23) |
Dose level 1 (n = 9) |
Dose level 2 (n = 14) |
|---|---|---|---|
| Age, y | 66 (50-80) | 67 (50-76) | 66 (54-80) |
| Male | 11 (48) | 4 (44) | 7 (50) |
| Time from diagnosis, months | 87.5 (30-209) | 91.5 (39-147) | 86.2 (30-209) |
| Bulky lymph nodes, >5 cm* | 8 (35) | 3 (33) | 5 (36) |
| SPD, cm2 | 25 (2-197) | 30 (2-119) | 25 (5-197) |
| LDH, U/L | 235 (1-1956) | 206 (153-1956) | 244 (1-651) |
| BALL risk score† | 2 (0-3) | 1 (1-3) | 3 (0-3) |
| Low risk (0-1) | 8 (35) | 5 (56) | 3 (21) |
| Medium risk (2-3) | 15 (65) | 4 (44) | 11 (79) |
| Disease stage | |||
| Rai stage III/IV | 15 (65) | 6 (67) | 9 (64) |
| Binet stage C | 16 (70) | 7 (78) | 9 (64) |
| High-risk features, any | 19 (83) | 6 (67) | 13 (93) |
| del(17p) | 8 (35) | 3 (33) | 5 (36) |
| Mutated TP53 | 14 (61) | 4 (44) | 10 (71) |
| Unmutated IGHV | 8 (35) | 4 (44) | 4 (29) |
| Complex karyotype‡ | 11 (48) | 5 (56) | 6 (43) |
| Lines of prior therapy | 4 (2-11) | 5 (3-8) | 4 (2-11) |
| Prior chemoimmunotherapy | 20 (87) | 8 (89) | 12 (86) |
| Prior ibrutinib | 23 (100) | 9 (100) | 14 (100) |
| Ibrutinib refractory/relapsed | 21 (91) | 9 (100) | 12 (86) |
| Ibrutinib intolerant | 6 (26) | 3 (33) | 3 (21) |
| BTKi as last prior therapy | 7 (30) | 2 (22) | 5 (36) |
| Prior venetoclax | 15 (65) | 5 (56) | 10 (71) |
| Venetoclax refractory/relapsed | 15 (65) | 5 (56) | 10 (71) |
| Prior ibrutinib and venetoclax | 15 (65) | 5 (56) | 10 (71) |
| BTKi progression/venetoclax failure§ | 11 (48) | 4 (44) | 7 (50) |
| Prior PI3Ki | 4 (17) | 1 (11) | 3 (21) |
| Received bridging therapy | 17 (74) | 5 (56) | 12 (86) |
Data are expressed as n (%) or median (range).
LDH, lactate dehydrogenase; SPD, sum of the product of perpendicular diameters.
*
Bulky disease was defined as ≥1 lesion with the longest diameter of >5 cm.
†
BALL is β2 microglobulin ≥5 mg/L, anemia, LDH greater than the upper limit of normal, and last therapy.17
‡
At least 3 chromosomal aberrations.
§
Venetoclax failure was defined as discontinuation due to progressive disease, intolerance, or not achieving a response after ≥3 mo of therapy.