Demographics and baseline characteristics
| Characteristic . | Phase 2 and Exp (n = 60) . | Phase 1b∗ (n = 17) . |
|---|---|---|
| Age, median (range), y | 75 (60-89) | 75 (60-86) |
| Age ≥75 y, n (%) | 31 (52) | 9 (53) |
| Gender, n (%) | ||
| Female | 31 (52) | 7 (41) |
| Male | 29 (48) | 10 (59) |
| Race, n (%) | n = 57 | |
| Caucasian | 47 (82) | 13 (76) |
| African American | 5 (9) | 0 (0) |
| Asian | 4 (7) | 4 (24) |
| Hispanic | 1 (2) | 0 (0) |
| Unknown | 3 | 0 |
| PS, n (%) | ||
| 0 | 16 (27) | 7 (41) |
| 1 | 32 (53) | 6 (35) |
| 2 | 12 (20) | 4 (24) |
| Hemoglobin, median (range), g/dL | 8.3 (6.8-13.1) | 9.1 (6.8-12.4) |
| Platelets, median (range), 109/L | 58 (5-517) | 91 (17-335) |
| WBC, median (range), 109/L | 3.2 (0.4-54.5) | 3 (0.9-54.5) |
| WBC >50, n (%) | 2 (3) | 1 (6) |
| Creatinine, U/L2 | 0.9 (0.5-1.9) | 0.9 (0.6-1.9) |
| LDH, U/L | 276.5 (104-3350) | 184 (131-500) |
| ALT, U/L3 | 20 (6-93) | 18 (8-33) |
| AST, U/L | 22 (7-74) | 19 (11-34) |
| Total bilirubin, mg/dL | 0.6 (0.2-1.6) | 0.6 (0.2-1.0) |
| Blood blasts, % | ||
| Median (range) | 26.5 (0-98) | 13 (0-46.8) |
| Not assessed/unknown | 6 | 3 |
| Bone marrow blasts, % | ||
| Median (range) | 52 (13-95) | 60 (13-95) |
| Not assessed/unknown | 1 | 0 |
| Treatment-related AML, n (%) | ||
| No | 54 (90) | 15 (88) |
| Yes | 6 (10) | 2 (12) |
| IDH2 mutation | ||
| Median VAF (range) | 40.5 (6-58) | 36 (14-51) |
| R140, n (%) | 44 (73) | 15 (88) |
| R172, n (%) | 16 (27) | 2 (12) |
| ELN risk, n (%) | ||
| Adverse | 32 (53) | 8 (47) |
| Intermediate | 17 (28) | 5 (29) |
| Favorable | 11 (18) | 4 (24) |
| Characteristic . | Phase 2 and Exp (n = 60) . | Phase 1b∗ (n = 17) . |
|---|---|---|
| Age, median (range), y | 75 (60-89) | 75 (60-86) |
| Age ≥75 y, n (%) | 31 (52) | 9 (53) |
| Gender, n (%) | ||
| Female | 31 (52) | 7 (41) |
| Male | 29 (48) | 10 (59) |
| Race, n (%) | n = 57 | |
| Caucasian | 47 (82) | 13 (76) |
| African American | 5 (9) | 0 (0) |
| Asian | 4 (7) | 4 (24) |
| Hispanic | 1 (2) | 0 (0) |
| Unknown | 3 | 0 |
| PS, n (%) | ||
| 0 | 16 (27) | 7 (41) |
| 1 | 32 (53) | 6 (35) |
| 2 | 12 (20) | 4 (24) |
| Hemoglobin, median (range), g/dL | 8.3 (6.8-13.1) | 9.1 (6.8-12.4) |
| Platelets, median (range), 109/L | 58 (5-517) | 91 (17-335) |
| WBC, median (range), 109/L | 3.2 (0.4-54.5) | 3 (0.9-54.5) |
| WBC >50, n (%) | 2 (3) | 1 (6) |
| Creatinine, U/L2 | 0.9 (0.5-1.9) | 0.9 (0.6-1.9) |
| LDH, U/L | 276.5 (104-3350) | 184 (131-500) |
| ALT, U/L3 | 20 (6-93) | 18 (8-33) |
| AST, U/L | 22 (7-74) | 19 (11-34) |
| Total bilirubin, mg/dL | 0.6 (0.2-1.6) | 0.6 (0.2-1.0) |
| Blood blasts, % | ||
| Median (range) | 26.5 (0-98) | 13 (0-46.8) |
| Not assessed/unknown | 6 | 3 |
| Bone marrow blasts, % | ||
| Median (range) | 52 (13-95) | 60 (13-95) |
| Not assessed/unknown | 1 | 0 |
| Treatment-related AML, n (%) | ||
| No | 54 (90) | 15 (88) |
| Yes | 6 (10) | 2 (12) |
| IDH2 mutation | ||
| Median VAF (range) | 40.5 (6-58) | 36 (14-51) |
| R140, n (%) | 44 (73) | 15 (88) |
| R172, n (%) | 16 (27) | 2 (12) |
| ELN risk, n (%) | ||
| Adverse | 32 (53) | 8 (47) |
| Intermediate | 17 (28) | 5 (29) |
| Favorable | 11 (18) | 4 (24) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ELN, European LeukemiaNet; LDH, lactate dehydrogenase.
The baseline characteristics of phase 1b patients were measured at the start of the study.