Patient characteristics at randomization
| . | DisC (n = 140) . | RIST (n = 141) . | P value . |
|---|---|---|---|
| Age, median (IQR; range), years | 61 (50-66; 18-75) | 61 (54-65; 19-74) | .73 |
| Sex, n (%) | .77 | ||
| Female | 64 (46) | 61 (43) | |
| Male | 76 (54) | 80 (57) | |
| ECOG, n (%) | .69 | ||
| 0-1 | 123 (88) | 127 (90) | |
| 2 | 17 (12) | 14 (10) | |
| HCT-CI, median (IQR; range) | 2 (0-3; 0-10) | 1 (0-3; 0-8) | .30 |
| BM blasts, median (IQR; range), % | 30 (15-50; 2-95) | 30 (18-50; 0-90) | .42 |
| AML type, n (%) | .25 | ||
| De novo | 110 (79) | 102 (72) | |
| sAML | 22 (16) | 33 (23) | |
| tAML | 8 (6) | 6 (4) | |
| Disease status, n (%) | .87 | ||
| Poor response | 90 (64) | 93 (66) | |
| Relapse | 50 (36) | 48 (34) | |
| ELN 2022 (reclassified), n (%) | .014 | ||
| Favorable | 22 (16) | 20 (14) | |
| Intermediate | 51 (36) | 75 (53) | |
| Adverse | 67 (48) | 46 (33) | |
| Genetic abnormalities, n (%) | |||
| t(8;21)(q22;q22.1)/RUNX1::RUNX1T1∗ | 6 (4) | 6 (4) | 1.0 |
| inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11† | 5 (4) | 3 (2) | .71 |
| bZIP in-frame–mutated CEBPA | 1 (1) | 2 (1) | 1.0 |
| Mutated NPM1 without FLT3-ITD‡ | 14 (10) | 13 (9) | .98 |
| Mutated NPM1 | 22 (16) | 25 (18) | .77 |
| FLT3-ITD | 24 (17) | 21 (15) | .72 |
| t(6;9)(p23.3;q34.1)/DEK::NUP214 | 4 (3) | 0 (0) | .13 |
| t(v;11q23.3)/KMT2A-rearranged, excluding KMT2A-PTD | 4 (3) | 2 (1) | .67 |
| inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/GATA2, MECOM(EVI1) | 2 (1) | 3 (2) | 1.0 |
| t(3q26.2;v)/MECOM(EVI1)-rearranged | 1 (1) | 2 (1) | 1.0 |
| Secondary-type mutations§ | 22 (16) | 22 (16) | 1.0 |
| Complex karyotype | 34 (24) | 16 (11) | .007 |
| abn(17p) or TP53mut | 23 (16) | 10 (7) | .025 |
| . | DisC (n = 140) . | RIST (n = 141) . | P value . |
|---|---|---|---|
| Age, median (IQR; range), years | 61 (50-66; 18-75) | 61 (54-65; 19-74) | .73 |
| Sex, n (%) | .77 | ||
| Female | 64 (46) | 61 (43) | |
| Male | 76 (54) | 80 (57) | |
| ECOG, n (%) | .69 | ||
| 0-1 | 123 (88) | 127 (90) | |
| 2 | 17 (12) | 14 (10) | |
| HCT-CI, median (IQR; range) | 2 (0-3; 0-10) | 1 (0-3; 0-8) | .30 |
| BM blasts, median (IQR; range), % | 30 (15-50; 2-95) | 30 (18-50; 0-90) | .42 |
| AML type, n (%) | .25 | ||
| De novo | 110 (79) | 102 (72) | |
| sAML | 22 (16) | 33 (23) | |
| tAML | 8 (6) | 6 (4) | |
| Disease status, n (%) | .87 | ||
| Poor response | 90 (64) | 93 (66) | |
| Relapse | 50 (36) | 48 (34) | |
| ELN 2022 (reclassified), n (%) | .014 | ||
| Favorable | 22 (16) | 20 (14) | |
| Intermediate | 51 (36) | 75 (53) | |
| Adverse | 67 (48) | 46 (33) | |
| Genetic abnormalities, n (%) | |||
| t(8;21)(q22;q22.1)/RUNX1::RUNX1T1∗ | 6 (4) | 6 (4) | 1.0 |
| inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11† | 5 (4) | 3 (2) | .71 |
| bZIP in-frame–mutated CEBPA | 1 (1) | 2 (1) | 1.0 |
| Mutated NPM1 without FLT3-ITD‡ | 14 (10) | 13 (9) | .98 |
| Mutated NPM1 | 22 (16) | 25 (18) | .77 |
| FLT3-ITD | 24 (17) | 21 (15) | .72 |
| t(6;9)(p23.3;q34.1)/DEK::NUP214 | 4 (3) | 0 (0) | .13 |
| t(v;11q23.3)/KMT2A-rearranged, excluding KMT2A-PTD | 4 (3) | 2 (1) | .67 |
| inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/GATA2, MECOM(EVI1) | 2 (1) | 3 (2) | 1.0 |
| t(3q26.2;v)/MECOM(EVI1)-rearranged | 1 (1) | 2 (1) | 1.0 |
| Secondary-type mutations§ | 22 (16) | 22 (16) | 1.0 |
| Complex karyotype | 34 (24) | 16 (11) | .007 |
| abn(17p) or TP53mut | 23 (16) | 10 (7) | .025 |
abn, chromosome abnormalities; BM, bone marrow; sAML, secondary AML; tAML, therapy-related AML.
Three patients had adverse ELN 2022: 1 patient with DisC due to complex karyotype, 1 patient with RIST due to del(5q), and 1 patient with RIST due to del(7).
One patient with DisC had adverse ELN 2022 due to a complex and monosomal karyotype and del(7).
Four patients (2 DisC and RIST each) had adverse-risk AML according to ELN 2022 due to complex karyotype.
Secondary-type mutations comprise ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2 mutations.