Table I.
Baseline patient and clinical characteristics
| Characteristic | Median [range], n (%) | ||||
|---|---|---|---|---|---|
| Arm A (N= 38) |
Arm B (N= 11) |
Total (N= 49) |
|||
| Age, years | 61.5 [24–76] | 56 [23–73] | 58 [23–76] | ||
| Male/Female | 20/18 | 5/6 | 25/24 | ||
| ECOG Performance Status | |||||
| 0 | 0 | 1 (9) | 1 (2) | ||
| 1 | 25 (66) | 5 (45) | 30 (61) | ||
| 2 | 10 (26) | 5 (45) | 15 (31) | ||
| 3 | 3 (8) | 0 (0) | 3 (6) | ||
| Type of Leukemia | |||||
| AML | 30 (79) | 9 (82) | 39 (80) | ||
| ALL | 7 (18) | 2 (18) | 9 (18) | ||
| CML | 1 (3) | 0 (0) | 1 (2) | ||
| Risk Status AML | CG | Mol. abn | CG | Mol. abn | |
| Favorable | 0 (0) | 1 (3) | 0 (0) | 0 (0) | 1 (3) |
| Intermediate risk | 13 (43) | 0 (0) | 3 (33) | 0 (0) | 16 (41) |
| Poor risk | 17 (57) | 0 (0) | 6 (67) | 1 (11) | 23 (59) |
| ALL | |||||
| B cell | 4 (57) | 0 (0) | 4 (44) | ||
| T cell | 3 (43) | 2 (100) | 5 (56) | ||
| Prior Stem Cell Transplant | 12 (32) | 6 (55) | 18 (37) | ||
| No. of prior therapies | 5 [2–10] | 5 [2–9] | 5 [2–10] | ||
| ≥3 prior therapies | 33 (87) | 8 (78) | 41 (84) | ||
Arm A; Daily IV evofosfamide administration, Arm B; continuous evofosfamide administration CG, cytogenetics; Mol. abn, molecular abnormalities