Table 1.
Patient characteristics
| Characteristic | Treatment group | |
|---|---|---|
| Omidubicel | Standard UCB | |
| Total no. of patients randomly assigned | 62 (100) | 63 (100) |
| Sex | ||
| Female | 30 (48) | 23 (36) |
| Male | 32 (52) | 40 (64) |
| Age, y | ||
| Median (range) | 40 (13-62) | 43 (13-65) |
| 12-17 | 8 (13) | 6 (10) |
| 18-39 | 23 (37) | 23 (36) |
| 40-59 | 27 (44) | 31 (49) |
| 60-65 | 4 (6) | 3 (5) |
| Median weight, kg (range) | 78.6 (43-134) | 77.4 (46-133) |
| Race | ||
| White | 35 (57) | 37 (59) |
| Black | 11 (18) | 9 (14) |
| Asian | 7 (11) | 10 (16) |
| Hispanic or Latino | 10 (16) | 6 (10) |
| Other/unknown | 9 (14) | 7 (11) |
| Primary diagnosis | ||
| Acute myeloid leukemia | 27 (43) | 33 (52) |
| CR1 (morphologic) | 18 | 22 |
| CR2 | 9 | 11 |
| Acute lymphoblastic leukemia | 20 (32) | 21 (34) |
| High-risk CR1 (morphologic) | 13 | 11 |
| CR2 (morphologic) | 6 | 10 |
| CR3+ (morphologic) | 1 | 0 |
| Myelodysplastic syndrome | 6 (10) | 3 (5) |
| High | 2 | 0 |
| Intermediate-1 | 3 | 1 |
| Intermediate-2 | 1 | 2 |
| Chronic myeloid leukemia | 4 (7) | 2 (3) |
| Lymphoma | 3 (5) | 2 (3) |
| Hodgkin lymphoma, stable disease | 0 | 1 |
| T-cell non-Hodgkin lymphoma | 3 | 1 |
| Other rare disease | 2 (3) | 2 (3) |
| Adult T-cell leukemia/ lymphoma CR1 | 1 | 0 |
| Biphenotypic leukemia | 0 | 1 |
| Dendritic cell leukemia | 1 | 1 |
| Disease risk group | ||
| Low | 15 (24) | 15 (23) |
| Moderate | 27 (44) | 25 (40) |
| High/very high | 20 (32) | 23 (37) |
| HSCT-specific comorbidity index | ||
| 0 | 12 (19) | 13 (20) |
| 1-2 | 19 (31) | 18 (29) |
| 3+ | 31 (50) | 32 (51) |
| Intended UCB transplant | ||
| Single | 20 (32) | 21 (33) |
| Double | 42 (68) | 42 (67) |
| Antigen-level HLA match score (intended treatment CBU #1) | ||
| 4/6 | 46 (74) | 46 (73) |
| 5/6 | 15 (24) | 16 (25) |
| 6/6 | 1 (2) | 1 (2) |
| Antigen-level HLA match score (intended treatment CBU #2) | ||
| 4/6 | 31 (49) | |
| 5/6 | 10 (16) | |
| 6/6 | 1 (2) | |
| Conditioning regimens | ||
| TBI 1350 cGy, fludarabine 160 mg/m2, thiotepa 10 mg/kg | 7 (11) | 9 (15) |
| TBI 1320 cGy, fludarabine 75 mg/m2, cyclophosphamide 120 mg/kg | 24 (39) | 21 (33) |
| Thiotepa 10 mg/kg, busulfan 12.8 mg/kg, fludarabine 150 mg/m2 | 27 (44) | 28 (44) |
| Did not receive a transplant or off-protocol regimen | 4 (6) | 5 (8) |
All data are n (%), unless otherwise stated.
CR1, first complete response; TBI, total body irradiation.