Table 3. Summary of Response and Day +100 Post-HSCT Survival among All Patients and by Treatment Arm.
| Characteristic | Arm A | Arm B | Total | P (A vs B) |
|---|---|---|---|---|
| CR, n/N (%) (evaluable population) | ||||
| Overall* | 35/72 (49) | 30/69 (43) | 65/141 (46) | .613 |
| Adult | 19/49 (39) | 19/45 (42) | 38/94 (40) | .734 |
| Pediatric | 16/23 (70) | 11/24 (46) | 27/47 (57) | .100 |
| Previous sirolimus/tacrolimus | 12/28 (43) | 9/22 (41) | 21/50 (42) | .890 |
| No previous sirolimus/tacrolimus | 23/44 (52) | 21/47 (45) | 44/91 (48) | .469 |
| Previous gemtuzumab ozogamicin | 5/8 (63) | 6/11 (55) | 11/19 (58) | .729 |
| No previous gemtuzumab ozogamicin | 30/64 (47) | 24/58 (41) | 54/122 (44) | .542 |
| Day +100 survival, n/N (%) (treated population) | ||||
| Overall | 33/75 (44) | 29/74 (39) | 62/149 (42) | .619 |
| Adult | 17/52 (33) | 20/49 (41) | 37/101 (37) | .397 |
| Pediatric | 16/23 (70) | 9/25 (36) | 25/48 (52) | .020 |
| Previous sirolimus/tacrolimus | 9/31 (29) | 9/24 (38) | 18/55 (33) | .507 |
| No previous sirolimus/tacrolimus | 24/44 (55) | 20/50 (40) | 44/94 (47) | .158 |
| Previous gemtuzumab ozogamicin | 5/9 (56) | 5/11 (46) | 10/20 (50) | .653 |
| No previous gemtuzumab ozogamicin | 28/66 (42) | 24/63 (38) | 52/129 (40) | .616 |
HSCT indicates hematopoietic stem cell transplantation; CR, complete response.
*
Of the 35 patients in arm A who achieved CR, 1 did so by day 7, 6 by day 14, 5 by day 21, 9 by day 28, and 14 after day 29. In arm B, the corresponding numbers were 2, 5, 0, 13, and 10 patients.