TABLE IV.
Response Summary for Patients With ALL
| AAML0523 (ALL only) n = 21
|
AAML0523 (Dose: 40 mg/m2) n = 8
|
AAML0523 (Dose: 52 mg/m2) n = 13
|
P-value | ||||
|---|---|---|---|---|---|---|---|
| N | % | N | % | N | % | ||
| Course 1 response | |||||||
| CR: complete response | 3 | 14% | 1 | 13% | 2 | 15% | 1.000 |
| SD: stable disease | 6 | 29% | 2 | 25% | 4 | 38% | 0.197 |
| PD: progressive disease | 3 | 14% | 2 | 25% | 1 | 8% | 0.531 |
| PRCL: partial remission—cytolytic | 4 | 19% | 1 | 13% | 3 | 23% | 1.000 |
| MRCL: minimal response—cytolytic | 5 | 24% | 2 | 25% | 3 | 15% | 0.618 |
| Is patient off protocol therapy at end of course 1? | |||||||
| No | 11 | 52% | 4 | 50% | 7 | 54% | 1.000 |
| Yes | 10 | 48% | 4 | 50% | 6 | 46% | |
| Course 2 response | |||||||
| CR: complete response | 2 | 18% | 1 | 25% | 1 | 14% | 1.000 |
| Death (in CR) | 1 | 9% | 0 | 0% | 1 | 14% | 1.000 |
| PR: partial response | 1 | 9% | 1 | 25% | 0 | 0% | 0.381 |
| PD: progressive disease | 2 | 18% | 1 | 25% | 1 | 14% | 1.000 |
| SD: stable disease | 4 | 36% | 1 | 25% | 3 | 43% | 1.000 |
| MRCL: minimal response—cytolytic | 1 | 9% | 0 | 0% | 1 | 14% | 1.000 |
| Best response | |||||||
| CR: complete response | 3 | 14% | 1 | 13% | 2 | 15% | 1.000 |
| PR: partial response | 1 | 5% | 1 | 13% | 0 | 0% | 0.381 |
| PRCL: partial remission—cytolytic | 4 | 19% | 1 | 13% | 3 | 23% | 1.000 |
| MRCL: minimal response—cytolytic | 4 | 19% | 1 | 13% | 3 | 23% | 1.000 |
| SD: stable disease | 6 | 29% | 2 | 25% | 4 | 31% | 1.000 |
| PD: progressive disease | 3 | 14% | 2 | 25% | 1 | 8% | 0.531 |