Baseline characteristics across treatment cohorts
| . | Omidubicel (n = 52) . | UCB (n = 56) . | MMUD (n = 65) . | MUD (n = 450) . | Haploidentical (n = 328) . | P value . |
|---|---|---|---|---|---|---|
| Median follow-up (95% CI), mo | 48.1 (38.8-51.8) | 46.2 (36.2-49.5) | 23.7 (14.3-24.3) | 23.1 (17.7-23.9) | 13.0 (12.5-19.3) | |
| Age at transplant, mean ± SD, y | 38.90 ± 16.04 | 35.65 ± 15.11 | 42.92 ± 15.23 | 45.82 ± 13.82 | 40.00 ± 15.30 | <.001∗ |
| Male, n (%) | 27 (51.92) | 35 (62.50) | 32 (49.23) | 268 (59.56) | 186 (56.71) | .42 |
| Race, n (%) | <.001∗ | |||||
| White | 31 (59.62) | 29 (51.79) | 33 (50.77) | 367 (81.56) | 195 (59.45) | |
| Non-White/other | 21 (40.38) | 27 (48.21) | 32 (49.23) | 83 (18.44) | 133 (40.55) | |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 9 (17.31) | 6 (10.71) | 13 (20.00) | 29 (6.44) | 79 (24.09) | <.001∗ |
| Other/unknown | 43 (82.69) | 50 (89.29) | 52 (80.00) | 421 (93.56) | 249 (75.91) | |
| Malignancy, n (%) | <.01∗ | |||||
| AML | 22 (42.31) | 27 (48.21) | 25 (38.46) | 158 (35.11) | 116 (35.37) | |
| ALL | 18 (34.62) | 19 (33.93) | 24 (36.92) | 118 (26.22) | 99 (30.18) | |
| MDS | 5 (9.62) | 3 (5.36) | 8 (12.31) | 118 (26.22) | 58 (17.68) | |
| CML | 4 (7.69) | 2 (3.57) | 4 (6.15) | 16 (3.56) | 18 (5.49) | |
| Lymphoma | 2 (3.85) | 3 (5.36) | 3 (4.62) | 37 (8.22) | 34 (10.37) | |
| Other | 1 (1.92) | 2 (3.57) | 1 (1.54) | 3 (0.67) | 3 (0.91) | |
| Karnofsky/Lansky performance score <90, n (%) | 12 (23.08) | 14 (25.00) | 24 (36.92) | 170 (37.78) | 131 (39.94) | .06 |
| HCT-CI ≥3, n (%) | 27 (51.92) | 28 (50.00) | 29 (44.62) | 201 (44.67) | 137 (41.77) | .59 |
| Body weight, mean ± SD, kg | 77.99 ± 21.22 | 77.54 ± 19.64 | 79.93 ± 25.14 | 85.69 ± 22.29 | 85.86 ± 23.47 | <.01∗ |
| TBI used in conditioning regimen, n (%) | 27 (51.92) | 28 (50.00) | 27 (41.54) | 131 (29.11) | 183 (55.79) | <.001∗ |
| Year of transplant, n (%) | <.001∗ | |||||
| 2017 | 5 (9.62) | 4 (7.14) | 35 (53.85) | 206 (45.78) | 113 (34.45) | |
| 2018 | 14 (26.92) | 19 (33.93) | 22 (33.85) | 157 (34.89) | 109 (33.23) | |
| 2019/2020 | 33 (63.46) | 33 (58.93) | 8 (12.31) | 87 (19.33) | 106 (32.32) | |
| GVHD prophylaxis, n (%) | ||||||
| PTCy-based regimen | 0 | 0 | 28 (38.36) | 65 (13.71) | 328 (100) | |
| CNI + MTX (without PTCy) | 0 | 0 | 35 (47.95) | 299 (63.08) | 0 | |
| CNI + MMF (without PTCy) | 52 (100) | 56 (100) | 2 (2.74) | 38 (8.02) | 0 | |
| Other CNI-based regimen (without PTCy) | 0 | 0 | 6 (8.22) | 33 (6.96) | 0 | |
| Ex vivo T-cell depletion/CD34 selection | 0 | 0 | 1 (1.37) | 34 (7.17) | 0 | |
| Other | 0 | 0 | 1 (1.37) | 4 (0.84) | 0 | |
| Not reported | 0 | 0 | 0 | 1 (0.21) | 0 |
| . | Omidubicel (n = 52) . | UCB (n = 56) . | MMUD (n = 65) . | MUD (n = 450) . | Haploidentical (n = 328) . | P value . |
|---|---|---|---|---|---|---|
| Median follow-up (95% CI), mo | 48.1 (38.8-51.8) | 46.2 (36.2-49.5) | 23.7 (14.3-24.3) | 23.1 (17.7-23.9) | 13.0 (12.5-19.3) | |
| Age at transplant, mean ± SD, y | 38.90 ± 16.04 | 35.65 ± 15.11 | 42.92 ± 15.23 | 45.82 ± 13.82 | 40.00 ± 15.30 | <.001∗ |
| Male, n (%) | 27 (51.92) | 35 (62.50) | 32 (49.23) | 268 (59.56) | 186 (56.71) | .42 |
| Race, n (%) | <.001∗ | |||||
| White | 31 (59.62) | 29 (51.79) | 33 (50.77) | 367 (81.56) | 195 (59.45) | |
| Non-White/other | 21 (40.38) | 27 (48.21) | 32 (49.23) | 83 (18.44) | 133 (40.55) | |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 9 (17.31) | 6 (10.71) | 13 (20.00) | 29 (6.44) | 79 (24.09) | <.001∗ |
| Other/unknown | 43 (82.69) | 50 (89.29) | 52 (80.00) | 421 (93.56) | 249 (75.91) | |
| Malignancy, n (%) | <.01∗ | |||||
| AML | 22 (42.31) | 27 (48.21) | 25 (38.46) | 158 (35.11) | 116 (35.37) | |
| ALL | 18 (34.62) | 19 (33.93) | 24 (36.92) | 118 (26.22) | 99 (30.18) | |
| MDS | 5 (9.62) | 3 (5.36) | 8 (12.31) | 118 (26.22) | 58 (17.68) | |
| CML | 4 (7.69) | 2 (3.57) | 4 (6.15) | 16 (3.56) | 18 (5.49) | |
| Lymphoma | 2 (3.85) | 3 (5.36) | 3 (4.62) | 37 (8.22) | 34 (10.37) | |
| Other | 1 (1.92) | 2 (3.57) | 1 (1.54) | 3 (0.67) | 3 (0.91) | |
| Karnofsky/Lansky performance score <90, n (%) | 12 (23.08) | 14 (25.00) | 24 (36.92) | 170 (37.78) | 131 (39.94) | .06 |
| HCT-CI ≥3, n (%) | 27 (51.92) | 28 (50.00) | 29 (44.62) | 201 (44.67) | 137 (41.77) | .59 |
| Body weight, mean ± SD, kg | 77.99 ± 21.22 | 77.54 ± 19.64 | 79.93 ± 25.14 | 85.69 ± 22.29 | 85.86 ± 23.47 | <.01∗ |
| TBI used in conditioning regimen, n (%) | 27 (51.92) | 28 (50.00) | 27 (41.54) | 131 (29.11) | 183 (55.79) | <.001∗ |
| Year of transplant, n (%) | <.001∗ | |||||
| 2017 | 5 (9.62) | 4 (7.14) | 35 (53.85) | 206 (45.78) | 113 (34.45) | |
| 2018 | 14 (26.92) | 19 (33.93) | 22 (33.85) | 157 (34.89) | 109 (33.23) | |
| 2019/2020 | 33 (63.46) | 33 (58.93) | 8 (12.31) | 87 (19.33) | 106 (32.32) | |
| GVHD prophylaxis, n (%) | ||||||
| PTCy-based regimen | 0 | 0 | 28 (38.36) | 65 (13.71) | 328 (100) | |
| CNI + MTX (without PTCy) | 0 | 0 | 35 (47.95) | 299 (63.08) | 0 | |
| CNI + MMF (without PTCy) | 52 (100) | 56 (100) | 2 (2.74) | 38 (8.02) | 0 | |
| Other CNI-based regimen (without PTCy) | 0 | 0 | 6 (8.22) | 33 (6.96) | 0 | |
| Ex vivo T-cell depletion/CD34 selection | 0 | 0 | 1 (1.37) | 34 (7.17) | 0 | |
| Other | 0 | 0 | 1 (1.37) | 4 (0.84) | 0 | |
| Not reported | 0 | 0 | 0 | 1 (0.21) | 0 |
Sex, Karnofsky performance score, and HCT-CI were similar across arms. Compared to the CIBMTR cohorts, patients on the omidubicel trial were younger at the time of transplant and more likely to have a diagnosis of AML than other malignancies. Significantly more White patients were in the 8/8 MUD arm than other arms. Other differences between the treatment arms included body weight, use of TBI in conditioning, and year of transplant.
ALL, acute lymphoblastic leukemia; CML, chronic myeloid leukemia; CNI, calcineurin inhibitor; HCT-CI, HCT comorbidity index; MDS, myelodysplastic syndrome; MMF, mycophenolate mofetil; MTX, methotrexate; SD, standard deviation; TBI, total body irradiation.