Demographics and baseline characteristics of trial participants
| Characteristic . | Participants (54 total) . |
|---|---|
| Mean age, y (range) | 60 (21-84) |
| Sex | |
| Male | 27 (50%) |
| Female | 27 (50%) |
| ECOG performance status | |
| 0 | 7 (13%) |
| 1 | 41 (76%) |
| 2 | 6 (11%) |
| Number of prior treatment regimens | |
| Median | 3 |
| Range | 1-7 |
| Prior treatment with intensive therapy∗ | 41 (75.9%) |
| Prior treatment with venetoclax | 21 (38.9%) |
| Prior allogeneic transplant | 6 (11%) |
| ELN 2022 classification | |
| Favorable | 0 |
| Intermediate | 27 (50%) |
| Adverse | 13 (24%) |
| Insufficient data to classify | 14 (26%) |
| FLT3 mutation status at enrollment | |
| FLT3 wild-type | 24 (44.4%) |
| FLT3-ITD | 24 (44%) |
| FLT3-TKD | 4 (7%) |
| FLT3 noncanonical | 2 (4%) |
| Prior FLT3 inhibitor treatment | |
| None | 24 (44%) |
| Midostaurin | 5 (9%) |
| Sorafenib | 4 (7%) |
| Gilteritinib | 8 (15%) |
| Multiple | 13 (24%) |
| Total with prior FLT3 inhibitor | 30 (56%) |
| Characteristic . | Participants (54 total) . |
|---|---|
| Mean age, y (range) | 60 (21-84) |
| Sex | |
| Male | 27 (50%) |
| Female | 27 (50%) |
| ECOG performance status | |
| 0 | 7 (13%) |
| 1 | 41 (76%) |
| 2 | 6 (11%) |
| Number of prior treatment regimens | |
| Median | 3 |
| Range | 1-7 |
| Prior treatment with intensive therapy∗ | 41 (75.9%) |
| Prior treatment with venetoclax | 21 (38.9%) |
| Prior allogeneic transplant | 6 (11%) |
| ELN 2022 classification | |
| Favorable | 0 |
| Intermediate | 27 (50%) |
| Adverse | 13 (24%) |
| Insufficient data to classify | 14 (26%) |
| FLT3 mutation status at enrollment | |
| FLT3 wild-type | 24 (44.4%) |
| FLT3-ITD | 24 (44%) |
| FLT3-TKD | 4 (7%) |
| FLT3 noncanonical | 2 (4%) |
| Prior FLT3 inhibitor treatment | |
| None | 24 (44%) |
| Midostaurin | 5 (9%) |
| Sorafenib | 4 (7%) |
| Gilteritinib | 8 (15%) |
| Multiple | 13 (24%) |
| Total with prior FLT3 inhibitor | 30 (56%) |
FLT3 noncanonical mutations refer to putative activating mutations of FLT3 that are neither ITD nor TKD. The 2 such mutations listed were A680V and V491L.
ECOG, Eastern Cooperative Oncology Group; ELN, European LeukemiaNet.
Intensive therapy is defined as infusional cytarabine combined with daunorubicin or idarubicin (7+3), CPX-351, high-dose cytarabine, or fludarabine-cytarabine-idarubicin (Ida-FLAG).