Table 1.
Baseline prevalence of CLL-associated mutations and genomic risk features.
| FD cohort plus MRD cohort placebo arm | FD cohort onlya | ||||
|---|---|---|---|---|---|
| Prevalence, n/N (%) | PD, n = 29 | No PDb, n = 161 | PD, n = 24 | No PDb, n = 123 | |
| Genes recurrently mutated in CLL | ATM | 10/29 (34) | 44/161 (27) | 9/24 (38) | 30/123 (24) |
| BIRC3 | 0/29 (0) | 11/161 (7) | 0/24 (0) | 8/123 (7) | |
| BRAF | 1/29 (3) | 11/161 (7) | 0/24 (0) | 7/123 (6) | |
| CHD2 | 3/29 (10) | 11/161 (7) | 1/24 (4) | 10/123 (8) | |
| EZH2 | 0/29 (0) | 0/161 (0) | 0/24 (0) | 0/123 (0) | |
| FBXW7 | 1/29 (3) | 8/161 (5) | 0/24 (0) | 7/123 (6) | |
| MYD88 | 2/29 (7) | 10/161 (6) | 2/24 (8) | 10/123 (8) | |
| NOTCH1 | 8/29 (28) | 34/161 (21) | 6/24 (25) | 24/123 (20) | |
| POT1 | 2/29 (7) | 22/161 (14) | 2/24 (8) | 13/123 (11) | |
| RPS15 | 0/29 (0) | 11/161 (7) | 0/24 (0) | 8/123 (7) | |
| SF3B1 | 8/29 (28) | 29/161 (18) | 6/24 (25) | 22/123 (18) | |
| XPO1 | 2/29 (7) | 10/161 (6) | 2/24 (8) | 6/123 (5) | |
| Genomic risk featuresc | Unmutated IGHV | 22/29 (76) | 90/157 (57) | 17/24 (71) | 65/120 (54) |
| Complex karyotype | 8/26 (31) | 26/137 (19) | 8/21 (38) | 22/103 (21) | |
| del(17p) | 5/29 (17) | 16/158 (10) | 5/24 (21) | 15/121 (12) | |
| del(11q) | 9/29 (31) | 27/160 (17) | 8/24 (33) | 20/122 (16) | |
| Trisomy 12 | 6/29 (21) | 27/158 (17) | 4/24 (17) | 21/121 (17) | |
| del(13q) | 15/29 (52) | 92/161 (57) | 14/24 (58) | 69/123 (56) | |
| TP53 mutated | 4/29 (14) | 11/161 (7) | 4/24 (17) | 10/123 (8) | |
| del(17p) and/or TP53 mutated | 7/29 (24) | 20/158 (13) | 7/24 (29) | 18/121 (15) | |
Note: Nominal P-values, determined using the FDR-corrected Fisher exact test, were >0.05 for all comparisons.
aTo minimize potential bias, analysis of baseline prevalence was restricted to 147 patients from the FD cohort (24 patients with PD and 123 without PD).
bPatients who had not experienced PD as of the data cutoff date. One FD cohort patient with missing baseline data was excluded.
cRisk prevalences are shown in table. In the FD cohort plus MRD cohort placebo arm, FISH cytogenetic results per Döhner hierarchy in the PD and no PD groups, respectively, were as follows: del(17p), 17% and 10%; del(11q), 31% and 16%; trisomy 12, 14% and 16%; normal, 21% and 20%; and del(13q), 17% and 39%. In the FD cohort only, FISH cytogenetic results per Döhner hierarchy in the PD and no PD groups, respectively, were as follows: del(17p), 21% and 12%; del(11q), 33% and 15%; trisomy 12, 8% and 16%; normal, 17% and 20%; and del(13q), 21% and 37%.