Table 1.
Baseline Characteristics.
| HAM-pegA n (%) |
CLAG-M n (%) |
p-Value | |
|---|---|---|---|
| Age (years)—median (range) | 49 (28–61) | 52 (20–67) | NS |
| Female sex | 3 (30.0) | 16 (47.1) | NS |
| Race | 0.034 * | ||
| White | 5 (50.0) | 20 (60.6) | |
| Black | 2 (20.0) | 12 (36.4) | |
| Asian | 3 (30.0) | 1 (3.0) | |
| Other | - | 1 (3.0) | |
| ECOG | NS | ||
| ≤2 | 10 (100.0) | 27 (79.4) | |
| >2 | - | 4 (11.8) | |
| Missing data | - | 3 (8.8) | |
| Key Inclusion Criteria | NS | ||
| Primary refractory | 2 (20.0) | 14 (41.2) | |
| Relapsed disease | 8 (80.0) | 20 (58.8) | |
| FAB-Subtype | NS | ||
| M0 | - | 1 (2.9) | |
| M1 | 1 (10.0) | 4 (11.8) | |
| M2 | 3 (30.0) | 9 (26.5) | |
| M4 | 2 (20.0) | 6 (17.6) | |
| M5 | 3 (30.0) | 7 (20.6) | |
| M6 | - | 1 (2.9) | |
| Missing data | 1 (10.0) | 6 (17.6) | |
| Treatment-related AML | - | 4 (11.8) | NS |
| Previous Chemotherapy Received | |||
| 7 + 3 | 9 (90.0) | 29 (85.3) | NS |
| High dose cytarabine | 8 (80.0) | 18 (52.9) | |
| Decitabine or Azacitidine | 1 (10.0) | 7 (20.6) | |
| CLAG-M | - | 1 (2.9) | |
| Other non-cytotoxic therapy | 2 (20.0) | 5 (14.7) | |
| Previous allo-HSCT | 3 (30.0) | 5 (14.7) | NS |
| No. Previous CR | NS | ||
| 1 | 6 (60.0) | 18 (52.9) | |
| 2 | 2 (20.0) | 1 (2.9) | |
| Unknown | - | 1 (2.9) | |
| Bone marrow blasts—median (range) | 33 (4–65) | 40 (5–88) | NS |
| Cytogenetics | NS | ||
| Normal karyotype | 5 (50.0) | 12 (35.3) | |
| 1–2 karyotype abnormalities | 3 (30.0) | 8 (23.5) | |
| Complex karyotype | 2 (20.0) | 14 (41.2) | |
| Next-generation sequencing available ^ | 6 (60.0) | 17 (50.0) | NS |
| Mutations ^—n | |||
| ASXL1 | 1 | 3 | NS |
| c-KIT | - | 1 | |
| CEBPA | 1 | 1 | |
| FLT3-ITD | 2 | 4 | |
| FLT3-TKD | 2 | 3 | |
| IDH1 | - | 2 | |
| IDH2 | 1 | - | |
| NPM1 | 1 | 3 | |
| RUNX1 | 2 | 6 | |
| TP53 | - | 2 |
FAB = French-American-British classification of acute myeloid leukemia; * Denotes significance, p < 0.05; NS = not significant, ^ Next-generation sequencing to detect molecular abnormalities was not available on all patients. Molecular abnormalities are therefore reported as number of patients only.