Best response after 1 or 2 cycles of study therapy
| Response, n (%) . | CLAG-M/sorafenib RP2D cohort (n = 41), (%) . | CLAG-M control cohort (n = 76), (%) . | P value . |
|---|---|---|---|
| MRD– CR | 34 (83) | 58 (76) | .48 |
| MRD+ CR | 2 (5) | 2 (3) | — |
| CRi | — | ||
| MRD– | 1 (2) | 2 (3) | |
| MRD+ | 1 (2) | 1 (1) | |
| ORR (CR + CRi) | 38 (93) | 63 (83) | .17 |
| MLFS | — | ||
| MRD– | 0 | 4 (5) | |
| Resistant disease | 2 (5) | 5 (7) | — |
| Death indeterminate cause | 1 (2) | 4 (5) | — |
| 4-wk mortality | 1 (2) | 3 (4) | 1.00 |
| 8-wk mortality | 1 (2) | 5 (7) | .42 |
| 1-y OS | 80 | 72 | .20 |
| 1-y EFS | 76 | 64 | .06 |
| D to ANC ≥ 500/μL | 29 (20-50) | 27 (17-44) | .02 |
| D to ANC ≥ 1000/μL | 32 (21-50) | 29 (18-45) | .02 |
| D to platelets ≥ 50 000/μL | 27 (17-50) | 23 (17-42) | .06 |
| D to platelets ≥ 100 000/μL | 31 (18-50) | 26 (19-51) | .03 |
| Response, n (%) . | CLAG-M/sorafenib RP2D cohort (n = 41), (%) . | CLAG-M control cohort (n = 76), (%) . | P value . |
|---|---|---|---|
| MRD– CR | 34 (83) | 58 (76) | .48 |
| MRD+ CR | 2 (5) | 2 (3) | — |
| CRi | — | ||
| MRD– | 1 (2) | 2 (3) | |
| MRD+ | 1 (2) | 1 (1) | |
| ORR (CR + CRi) | 38 (93) | 63 (83) | .17 |
| MLFS | — | ||
| MRD– | 0 | 4 (5) | |
| Resistant disease | 2 (5) | 5 (7) | — |
| Death indeterminate cause | 1 (2) | 4 (5) | — |
| 4-wk mortality | 1 (2) | 3 (4) | 1.00 |
| 8-wk mortality | 1 (2) | 5 (7) | .42 |
| 1-y OS | 80 | 72 | .20 |
| 1-y EFS | 76 | 64 | .06 |
| D to ANC ≥ 500/μL | 29 (20-50) | 27 (17-44) | .02 |
| D to ANC ≥ 1000/μL | 32 (21-50) | 29 (18-45) | .02 |
| D to platelets ≥ 50 000/μL | 27 (17-50) | 23 (17-42) | .06 |
| D to platelets ≥ 100 000/μL | 31 (18-50) | 26 (19-51) | .03 |
HMA, hypomethylating agents (ie, azanucleosides); MLFS, morphologic leukemia–free state; ORR, overall response rate.