Table 4.
Best overall response (intent‐to‐treat analysis set)
|
60 mg/7‐day (DL1) N = 6 n (%) |
60 mg/14‐day (DL2) N = 7a n (%) |
40 mg/14‐day (DL‐1) N = 6 n (%) |
TOTAL N = 19 n (%) |
|
|---|---|---|---|---|
| Best Overall Response | ||||
| Morphologic leukemia‐free stateb | 1 (17) | 1 (14) | 0 | 2 (11) |
| CRcc | 5 (83) | 5 (71) | 4 (67) | 14 (74) |
| CRd | 4 (67) | 3 (43) | 2 (33) | 9 (47) |
| CRpe | 1 (17) | 0 | 1 (17) | 2 (11) |
| CRif | 0 | 2 (29) | 1 (17) | 3 (16) |
| Treatment failureg | 0 | 0 | 0 | 0 |
| No response | 0 | 0 | 1 (17) | 1 (5) |
| Not evaluable | 0 | 1 (14) | 1 (17) | 2 (11) |
| Recurrenceh | 0 | 0 | 0 | 0 |
CR, complete remission; CRc, composite complete remission; CRi, complete remission with incomplete hematologic recovery; CRp, complete remission with incomplete platelet recovery; DL, dose level.
One patient enrolled in the DL2 cohort discontinued on day 3 before receiving quizartinib.
Defined as <5% bone marrow blasts in an aspirate sample with marrow spicules and with a count of ≥200 nucleated cells, no blasts with Auer rods, and no persistence of extramedullary disease.
Defined as rates of CR + CRp + CRi.
Defined as morphologic leukemia‐free state and absolute neutrophil count ≥1000/mm3, platelet count ≥100,000/mm3, patient independent of transfusions.
Defined as CR except for platelet count <100,000/mm3.
Defined as CR except for absolute neutrophil count <1000/mm3 with or without platelet count <100,000/mm3. Transfusion independence not required.
Defined as failure to achieve a CR, CRp, or CRi.
Defined as relapse after CR, new dysplastic changes, reappearance or development of cytologically proven extramedullary disease, or reappearance of cytogenetic or molecular abnormality.