Summary of baseline characteristics
Baseline characteristics, N = 62, except when stated . | All patients N = 62 . | BTKi∗ + VEN w/wo CD20 mAb, n = 28 . | R-CHOP + VEN, n = 13 . | IC† + VEN, n = 21 . |
|---|---|---|---|---|
| n (%), or [range] . | ||||
| Age (years), median | 67 [43-83] | 65 [45-83] | 69 [43-77] | 65 [48-73] |
| ECOG PS sore of 2 or 3‡ | 8/56 (14) | 4/25 (16) | 2/12 (17) | 2/19 (11) |
| CLL | ||||
| Median no. of prior treatments | 2 [0-7] | 2 [0-7] | 1 [0-5] | 2 [0-5] |
| Prior therapies received | ||||
| Untreated | 11 (18) | 3 (11) | 4 (31) | 4 (19) |
| BTKi§ | 42 (68) | 22 (79) | 6 (46) | 14 (67) |
| VEN‖ | 15 (24) | 7 (25) | 5 (39) | 3 (14) |
| Chemoimmunotherapy | 34 (55) | 17 (61) | 6 (46) | 11 (52) |
| Allo-HSCT | 3 (5) | 3 (11) | 0 | 0 |
| Disease characteristics | ||||
| Unmutated IGHV, n = 59 | 52/59 (88) | 23/27 (85) | 10/11 (91) | 19/21 (91) |
| Deletion (17p), n = 59 | 31/59 (53) | 16/27 (59) | 4/13 (31) | 11/19 (58) |
| TP53 mutation, n = 37 | 16/37 (43) | 8/15 (53) | 2/9 (22) | 6/13 (46) |
| NOTCH1 mutation, n = 34 | 11/34 (32) | 3/11 (27) | 3/8 (38) | 5/15 (33) |
| Complex karyotype, n = 54 | 25/54 (46) | 13/27 (48) | 3/11 (27) | 9/16 (56) |
| RT | ||||
| Median time to RT from the diagnosis of CLL, years | 7 [0-28] | 8 [0-28] | 6 [0-15] | 7 [0-18] |
| Median no. of prior treatments for RT | 0 [0-10] | 2 [0-4] | 0 [0-4] | 0 [0-10] |
| Received chemotherapy for RT | 20 (32) | 12 (43) | 3 (23) | 5 (24) |
| Disease characteristics | ||||
| Clonally related, n = 14 | 12/14 (86) | 9/9 (100) | 2/3 (67) | 1/2 (50) |
| Complex karyotype, n = 18 | 16/18 (89) | 10/12 (83) | 2/2 (100) | 4/4 (100) |
| TP53 mutated, n = 19 | 11/19 (58) | 6/10 (60) | 0 | 5/9 (56) |
| TP53 deletion, n = 21 | 13/21 (62) | 7/12 (58) | 1/3 (33) | 5/6 (83) |
| NOTCH1 mutated, n = 14 | 6/14 (43) | 3/8 (38) | 1/2 (50) | 2/4 (50) |
| LDH, n = 58 | ||||
| >ULN | 44/58 (76) | 22/28 (79) | 6/11 (55) | 16/19 (84) |
| >2× ULN | 23/58 (40) | 9/28 (32) | 2/11 (18) | 12/19 (63) |
| Largest lymph node, n = 55 | ||||
| ≥5 cm | 25/55 (45) | 10/27 (37) | 5/10 (50) | 10/18 (56) |
| ≥10 cm | 8/55 (15) | 2/27 (7) | 1/10 (10) | 5/18 (28) |
| PET-CT (before VEN), n = 49 | ||||
| SUV >5 | 46/49 (94) | 20/22 (91) | 8/8 (100) | 18/19 (95) |
| SUV >10 | 33/49 (67) | 15/22 (68) | 6/8 (75) | 12/19 (63) |
| N/A | 13/62 (21) | 6/28 (21) | 5/13 (38) | 2/21 (10) |
Baseline characteristics, N = 62, except when stated . | All patients N = 62 . | BTKi∗ + VEN w/wo CD20 mAb, n = 28 . | R-CHOP + VEN, n = 13 . | IC† + VEN, n = 21 . |
|---|---|---|---|---|
| n (%), or [range] . | ||||
| Age (years), median | 67 [43-83] | 65 [45-83] | 69 [43-77] | 65 [48-73] |
| ECOG PS sore of 2 or 3‡ | 8/56 (14) | 4/25 (16) | 2/12 (17) | 2/19 (11) |
| CLL | ||||
| Median no. of prior treatments | 2 [0-7] | 2 [0-7] | 1 [0-5] | 2 [0-5] |
| Prior therapies received | ||||
| Untreated | 11 (18) | 3 (11) | 4 (31) | 4 (19) |
| BTKi§ | 42 (68) | 22 (79) | 6 (46) | 14 (67) |
| VEN‖ | 15 (24) | 7 (25) | 5 (39) | 3 (14) |
| Chemoimmunotherapy | 34 (55) | 17 (61) | 6 (46) | 11 (52) |
| Allo-HSCT | 3 (5) | 3 (11) | 0 | 0 |
| Disease characteristics | ||||
| Unmutated IGHV, n = 59 | 52/59 (88) | 23/27 (85) | 10/11 (91) | 19/21 (91) |
| Deletion (17p), n = 59 | 31/59 (53) | 16/27 (59) | 4/13 (31) | 11/19 (58) |
| TP53 mutation, n = 37 | 16/37 (43) | 8/15 (53) | 2/9 (22) | 6/13 (46) |
| NOTCH1 mutation, n = 34 | 11/34 (32) | 3/11 (27) | 3/8 (38) | 5/15 (33) |
| Complex karyotype, n = 54 | 25/54 (46) | 13/27 (48) | 3/11 (27) | 9/16 (56) |
| RT | ||||
| Median time to RT from the diagnosis of CLL, years | 7 [0-28] | 8 [0-28] | 6 [0-15] | 7 [0-18] |
| Median no. of prior treatments for RT | 0 [0-10] | 2 [0-4] | 0 [0-4] | 0 [0-10] |
| Received chemotherapy for RT | 20 (32) | 12 (43) | 3 (23) | 5 (24) |
| Disease characteristics | ||||
| Clonally related, n = 14 | 12/14 (86) | 9/9 (100) | 2/3 (67) | 1/2 (50) |
| Complex karyotype, n = 18 | 16/18 (89) | 10/12 (83) | 2/2 (100) | 4/4 (100) |
| TP53 mutated, n = 19 | 11/19 (58) | 6/10 (60) | 0 | 5/9 (56) |
| TP53 deletion, n = 21 | 13/21 (62) | 7/12 (58) | 1/3 (33) | 5/6 (83) |
| NOTCH1 mutated, n = 14 | 6/14 (43) | 3/8 (38) | 1/2 (50) | 2/4 (50) |
| LDH, n = 58 | ||||
| >ULN | 44/58 (76) | 22/28 (79) | 6/11 (55) | 16/19 (84) |
| >2× ULN | 23/58 (40) | 9/28 (32) | 2/11 (18) | 12/19 (63) |
| Largest lymph node, n = 55 | ||||
| ≥5 cm | 25/55 (45) | 10/27 (37) | 5/10 (50) | 10/18 (56) |
| ≥10 cm | 8/55 (15) | 2/27 (7) | 1/10 (10) | 5/18 (28) |
| PET-CT (before VEN), n = 49 | ||||
| SUV >5 | 46/49 (94) | 20/22 (91) | 8/8 (100) | 18/19 (95) |
| SUV >10 | 33/49 (67) | 15/22 (68) | 6/8 (75) | 12/19 (63) |
| N/A | 13/62 (21) | 6/28 (21) | 5/13 (38) | 2/21 (10) |
ECOG PS, Eastern Cooperative Oncology Group performance status; IC, intensive chemotherapy; LDH, lactate dehydrogenase; mAb, monoclonal antibody; N/A, not available; PET-CT, positron emission tomography–computed tomography; SUV, standardized uptake values; ULN, upper limit of normal; VEN, venetoclax; w/wo, with/without.
Twenty-six patients received ibrutinib, and 2 patients received acalabrutinib
Twelve patients received R-EPOCH: 3, ibrutinib + R-EPOCH; 1, acalabrutinib + R-EPOCH; 1, ibrutinib + R-hyper-CVAD; 1, R-hyper-CVAD; 1, ibrutinib + OFAR; 1, OFAR; and 1, methotrexate + cytarabine
No patients had ECOG PS score of 4.
In the BTKi + venetoclax group, reason for BTKi discontinuation was progressive CLL in 9 patients, RT in 11 patients, and adverse effects in 1 patient.
In the patients who received venetoclax for CLL, 12 developed RT during venetoclax therapy and their Richter therapy consisted of adding on the remainder of the regimen. In the BTKi + venetoclax group, 2 patients received allo-HSCT for CLL after achieving remission with venetoclax and another stopped venetoclax because of CLL progression.