Table 1. Demographics and baseline characteristics of obatoclax-treated patients (N = 18).
| Phase I | Phase II | All (N = 18) | |||
| 30 mg/d (3 h×3 d) (n = 3) | 20 mg/d (3 h×3 d) (n = 3) | 20 mg/d (3 h×3 d) (n = 7) | 60 mg/d (24 h×3 d) (n = 5) | ||
| Median (range) age, years | 83 (81–85) | 74 (72–90) | 82 (72–89) | 80 (76–86) | 81.5 (72–90) |
| Male, n (%) | 1 (33) | 1 (33) | 3 (43) | 3 (60) | 8 (44) |
| ECOG PS, n (%) | |||||
| 0 | 1 (33) | 0 | 3 (43) | 1 (20) | 5 (28) |
| 1 | 1 (33) | 1 (33) | 4 (57) | 2 (40) | 8 (44) |
| 2 | 1 (33) | 2 (67) | 0 | 2 (40) | 5 (28) |
| Median time since AML diagnosis, months (range) | 1 (0.5–7.4) | 1.2 (1–16.7) | 0.45 (−0.2–0.6) | 0.2 (0–37.2) | 0.6 (−0.2–37.2) |
| AML classification, n (%) | |||||
| M1 | 1 (33) | 0 | 3 (43) | 0 | 4 (22) |
| M2 | 2 (67) | 1 (33) | 3 (43) | 4 (80) | 10 (56) |
| M3 | 0 | 1 (33)* | 0 | 0 | 1 (6) |
| M4 | 0 | 1 (33) | 0 | 1 (20) | 2 (11) |
| Missing | 0 | 0 | 1 (14) | 0 | 1 (6) |
| Cytogenetics, n (%) | |||||
| Abnormal | 1 (33) | 3 (100) | 3 (43) | 3 (60) | 10 (56) |
| Normal | 1 (33) | 0 | 2 (29) | 2 (40) | 5 (28) |
| Missing | 1 (33) | 0 | 2 (29) | 0 | 3 (17) |
| Median leukocyte count (range), 103/µL | 1.3 (0.5–1.4) | 29.2 (19.3–64.3) | 4.3 (1.1–7.3) | 2.8 (1.1–27.2) | 4.25 (0.5–64.3) |
| Median platelet count (range), 103/µL | 23 (8–154) | 126 (69–227) | 63 (19–518) | 63 (19–259) | 66 (8–518) |
| Median hemoglobin (range), g/L | 86 (86–102) | 105 (99–110) | 101 (86–117) | 93 (90–100) | 97.5 (86–117) |
| Median neutrophil count (range), 103/µL | 0.2 (0.2–0.2)a | 1.95 (0.6–3.3)b | 0.39 (0.1–2.6)c | 6.98 (0.5–13.5)d | 0.55 (0.1–13.5)e |
*Classified as acute promyelocytic leukemia.
a
Evaluated in 1 patient.
b
Evaluated in 2 patients.
c
Evaluated in 5 patients.
d
Evaluated in 2 patients.
e
Evaluated in 10 patients.
AML, acute myeloid leukemia; ECOG PS, Eastern Cooperative Oncology Group performance status.