Table 1.
Baseline demographics and disease characteristics (full analysis set)
| Characteristic | Patients (N = 116) |
|---|---|
| Sex, n (%) | |
| Male | 68 (59) |
| Female | 48 (41) |
| Median (range) age, years | 45.0 (18-76) |
| Age group, years, n (%) | |
| 18 to <35 | 36 (31) |
| 35 to <55 | 41 (35) |
| 55 to <65 | 24 (21) |
| ≥65 | 15 (13) |
| Cytogenetics/molecular genetics, n (%) | |
| t(9;22)/BCR-ABL+ | 5 (4) |
| t(4;11)/MLL-AF4+ | 5 (4) |
| Relapse history, n (%)* | |
| Patients in first CR | 75 (65) |
| Patients in second CR | 39 (34) |
| Patients in third CR | 2 (2) |
| Median (range) time from last prior treatment, months | 2.0 (0-55) |
| Baseline MRD levels, n (%)† | |
| ≥10−1 to <1 (≥10% to <1) | 9 (8) |
| ≥10−2 to <10−1 (≥1% to <10%) | 45 (39) |
| ≥10−3 to <10−2 (≥0.1% to <1%) | 52 (45) |
| <10−3 (<0.1%) | 3 (3) |
| Below LLOQ | 5 (4) |
| Unknown‡ | 2 (2) |
LLOQ, lower limit of quantification.
*
One patient was ineligible (hematologic relapse).
†
Nine patients had MRD levels ≥10−1 with bone marrow cytology in central reference laboratory showing <5% blasts.
‡
Missing MRD assay results in central reference laboratory (n = 1); MRD quantification at baseline but with subsequent assessments (n = 1).