Patient summary
| Characteristic . | Study cohort (n = 22) . | Historical controls (n = 31) . | P value . |
|---|---|---|---|
| Age | |||
| Median (range), years | 42 (20-68) | 49 (15-65) | .464 |
| Sex | |||
| Male | 13 (59%) | 13 (42%) | .218 |
| Female | 9 (41%) | 18 (58%) | |
| Race | |||
| White | 13 (59.1%) | 17 (54.8%) | .915 |
| Hispanic | 6 (27.3%) | 9 (29%) | |
| Black | 2 (9.1%) | 2 (6.5%) | |
| Asian | 1 (4.5%) | 3 (9.7%) | |
| Weight | |||
| Median (range), kg | 79 (52-94) | 75 (43-144) | .454 |
| Body surface area | |||
| Median (range), m2 | 1.92 (1.54-2.19) | 1.9 (1.36-2.38) | .657 |
| Diagnosis | |||
| ALL | 3 (14%) | 4 (13%) | .4327 |
| AML/MDS | 12 (55%) | 20 (65%) | |
| CLL | 0 (0%) | 1 (3%) | |
| CML/MPD | 1 (5%) | 2 (6%) | |
| Hodgkin lymphoma | 3 (14%) | 0 (0%) | |
| Lymphoma | 3 (14%) | 4 (13%) | |
| Disease risk index | |||
| Intermediate | 13 (59%) | 11 (35.5%) | .233 |
| High | 7 (32%) | 15 (48.4%) | |
| Very high | 2 (9%) | 5 (16.1%) | |
| Conditioning regimen | |||
| Flu/Mel/ATG | 15 (68%) | 17 (55%) | .3997 |
| Flu/ Bu/+/− Clo/ATG/TBI 200 cGy | 7 (32%) | 14 (45%) | |
| Cryopreserved TNC dose (×107/kg), median (range) | |||
| Unmanipulated cord | 3.124 (2.23-5.9) | — | |
| Fucosylated cord | 2.38 (1.82-3.33) | — | |
| Total | 5.51 (4.3-8.1) | 4.78 (1.96-8.94) | .005 |
| Cryopreserved CD34 dose (×105/kg), median (range) | |||
| Unmanipulated cord | 1.15 (0.43-3.27) | — | |
| Fucosylated cord | 0.92 (0.28-2.09) | — | |
| Total | 2.38 (0.78-4.48) | 1.82 (0.39-9.92) | .154 |
| Infused TNC dose (×107/kg), median (range) | |||
| Unmanipulated cord | 2.59 (1.54-4.75) | — | |
| Fucosylated cord | 1.75 (0.64-2.5) | — | |
| Total | 4.26 (2.73-6.3) | 3.72 (1.5-7.0) | .220 |
| Donor HLA matchUnmanipulated CB unit | |||
| 4/6 | 11 (50%) | — | |
| 5/6 | 11 (50%) | — | |
| Fucosylated CB unit | |||
| 6/6 | 1 (5%) | — | |
| 5/6 | 10 (45%) | — | |
| 4/6 | 11 (50%) | — | |
| Combined CB units | |||
| 6/6 and 5/6 | 1 (4.5%) | 0 (0%) | .584 |
| 5/6 and 5/6 | 8 (36.3%) | 9 (29%) | |
| 5/6 and 4/6 | 4 (18.2%) | 6 (19.4%) | |
| 4/6 and 4/6 | 9 (40.9%) | 16 (51.6%) |
| Characteristic . | Study cohort (n = 22) . | Historical controls (n = 31) . | P value . |
|---|---|---|---|
| Age | |||
| Median (range), years | 42 (20-68) | 49 (15-65) | .464 |
| Sex | |||
| Male | 13 (59%) | 13 (42%) | .218 |
| Female | 9 (41%) | 18 (58%) | |
| Race | |||
| White | 13 (59.1%) | 17 (54.8%) | .915 |
| Hispanic | 6 (27.3%) | 9 (29%) | |
| Black | 2 (9.1%) | 2 (6.5%) | |
| Asian | 1 (4.5%) | 3 (9.7%) | |
| Weight | |||
| Median (range), kg | 79 (52-94) | 75 (43-144) | .454 |
| Body surface area | |||
| Median (range), m2 | 1.92 (1.54-2.19) | 1.9 (1.36-2.38) | .657 |
| Diagnosis | |||
| ALL | 3 (14%) | 4 (13%) | .4327 |
| AML/MDS | 12 (55%) | 20 (65%) | |
| CLL | 0 (0%) | 1 (3%) | |
| CML/MPD | 1 (5%) | 2 (6%) | |
| Hodgkin lymphoma | 3 (14%) | 0 (0%) | |
| Lymphoma | 3 (14%) | 4 (13%) | |
| Disease risk index | |||
| Intermediate | 13 (59%) | 11 (35.5%) | .233 |
| High | 7 (32%) | 15 (48.4%) | |
| Very high | 2 (9%) | 5 (16.1%) | |
| Conditioning regimen | |||
| Flu/Mel/ATG | 15 (68%) | 17 (55%) | .3997 |
| Flu/ Bu/+/− Clo/ATG/TBI 200 cGy | 7 (32%) | 14 (45%) | |
| Cryopreserved TNC dose (×107/kg), median (range) | |||
| Unmanipulated cord | 3.124 (2.23-5.9) | — | |
| Fucosylated cord | 2.38 (1.82-3.33) | — | |
| Total | 5.51 (4.3-8.1) | 4.78 (1.96-8.94) | .005 |
| Cryopreserved CD34 dose (×105/kg), median (range) | |||
| Unmanipulated cord | 1.15 (0.43-3.27) | — | |
| Fucosylated cord | 0.92 (0.28-2.09) | — | |
| Total | 2.38 (0.78-4.48) | 1.82 (0.39-9.92) | .154 |
| Infused TNC dose (×107/kg), median (range) | |||
| Unmanipulated cord | 2.59 (1.54-4.75) | — | |
| Fucosylated cord | 1.75 (0.64-2.5) | — | |
| Total | 4.26 (2.73-6.3) | 3.72 (1.5-7.0) | .220 |
| Donor HLA matchUnmanipulated CB unit | |||
| 4/6 | 11 (50%) | — | |
| 5/6 | 11 (50%) | — | |
| Fucosylated CB unit | |||
| 6/6 | 1 (5%) | — | |
| 5/6 | 10 (45%) | — | |
| 4/6 | 11 (50%) | — | |
| Combined CB units | |||
| 6/6 and 5/6 | 1 (4.5%) | 0 (0%) | .584 |
| 5/6 and 5/6 | 8 (36.3%) | 9 (29%) | |
| 5/6 and 4/6 | 4 (18.2%) | 6 (19.4%) | |
| 4/6 and 4/6 | 9 (40.9%) | 16 (51.6%) |
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; ATG, anti-thymocyte globulin; Bu, busulfan; CLL, chronic lymphoblastic leukemia; Clo, clofarabine; CML, chronic myeloid leukemia; Flu, fludarabine; MDS, myelodysplastic syndromes; Mel, melphalan; MPD, myeloproliferative disease; TBI, total body irradiation; —, data were not available or not applicable to historical controls.