Efficacy response
| Parameter . | Adult efficacy-evaluable population (n = 64) . |
|---|---|
| ORR, n (%) | 30 (46.9) |
| 95% CI | 34.3-59.8 |
| Time to first response, median (range), mo | 1.84 (0.9-4.6) |
| Duration of first response, median (95% CI), mo | 4.4 (1.2-5.6) |
| CR + CRh rate, n (%) | 15 (23.4) |
| 95% CI | 13.8-35.7 |
| P value, 1-sided | .0014 |
| Time to first CR + CRh, median (range), mo | 2.76 (1.8-8.8) |
| Duration of CR + CRh, median (95% CI), mo | 4.7 (1.2-8.2) |
| CRc, n (%) | 19 (29.7) |
| 95% CI | 18.9-42.4 |
| Best response, n (%) | |
| CR | 12 (18.8) |
| CRh | 3 (4.7) |
| CRi∗ | 2 (3.1) |
| CRp∗ | 2 (3.1) |
| MLFS | 9 (14.1) |
| PR | 2 (3.1) |
| No response | 19 (29.7) |
| Disease progression | 5 (7.8) |
| Other† | 10 (15.6) |
| No. of responders who proceeded to HSCT, n/N (%) | 5/30 (16.7) |
| Resumed treatment after HSCT, n/N (%) | 3/5 (60.0) |
| Parameter . | Adult efficacy-evaluable population (n = 64) . |
|---|---|
| ORR, n (%) | 30 (46.9) |
| 95% CI | 34.3-59.8 |
| Time to first response, median (range), mo | 1.84 (0.9-4.6) |
| Duration of first response, median (95% CI), mo | 4.4 (1.2-5.6) |
| CR + CRh rate, n (%) | 15 (23.4) |
| 95% CI | 13.8-35.7 |
| P value, 1-sided | .0014 |
| Time to first CR + CRh, median (range), mo | 2.76 (1.8-8.8) |
| Duration of CR + CRh, median (95% CI), mo | 4.7 (1.2-8.2) |
| CRc, n (%) | 19 (29.7) |
| 95% CI | 18.9-42.4 |
| Best response, n (%) | |
| CR | 12 (18.8) |
| CRh | 3 (4.7) |
| CRi∗ | 2 (3.1) |
| CRp∗ | 2 (3.1) |
| MLFS | 9 (14.1) |
| PR | 2 (3.1) |
| No response | 19 (29.7) |
| Disease progression | 5 (7.8) |
| Other† | 10 (15.6) |
| No. of responders who proceeded to HSCT, n/N (%) | 5/30 (16.7) |
| Resumed treatment after HSCT, n/N (%) | 3/5 (60.0) |
MLFS, morphological leukemia-free state; PR, partial remission.
CRi per European LeukemiaNet 2017 was defined as all CR criteria except for residual neutropenia (<1 × 109/L) or thrombocytopenia (<100 × 109/L). CRp was defined as all CR criteria except for platelet count <100 × 109/L.27
Includes patients not evaluable due to death (n = 9, none were treatment related) or withdrew consent (n = 1) before a postbaseline disease assessment could be obtained.