Table 2.
Outcomes | DEC10-VEN (N=65) | IC (N=130) |
OR / HR (95% CI) | Stratified p |
---|---|---|---|---|
Overall response rate (ORR) | 37 (60) | 36 (28) | 3.28 (1.73, 6.23) | <.001 |
CR/CRi | 27 (42) | 30 (23) | 2.52 (1.26, 5.03) | .009 |
CR | 15 (23) | 22 (17) | 1.44 (0.70, 2.94) | .320 |
CRi | 12 (19) | 8 (6) | 3.56 (1.32, 9.61) | .012 |
MLFS | 10 (15) | 6 (5) | 3.33 (1.21, 9.17) | .020 |
MRD negativity | 18 (28) | 17 (13) | 2.48 (1.17, 5.24) | .017 |
Refractory | 22 (35) | 71 (55) | 0.46 (0.25, 0.84) | .011 |
Inevaluable1 | 1 (2) | 1 (1) | 2.00 (0.13, 31.98) | .624 |
Relapse | 19 (51) | 17 (47) | 0.75 (0.24, 2.38) | .630 |
30-day mortality | 5 (8) | 16 (12) | 0.58 (0.2, 1.70) | .322 |
60-day mortality | 8 (12) | 35 (27) | 0.40 (0.18, 0.91) | .029 |
Results reported as n (%), n/N (%). ORR = CR+CRi+MLFS, CR = complete remission; CRi = CR with incomplete hematologic recovery, MLFS = morphologic leukemia-free state. MRD = minimal residual disease evaluated using multiparametric flow cytometry validated to a sensitivity level of 0.1–0.01%; OR = odds ratio; HR = hazard ratio, NA= not applicable,
One patient was taken off DEC10-VEN after receiving only 2 days of therapy and another patient was taken off IC after 1 day off therapy due to adverse event