Characteristics of patients according to transplantation centers and cohorts
. | Cohort I Center 1 . | Cohort II Center 2 . | Cohort II Center 3 . | Cohort II Center 4 . | Cohort II Center 5 . | P . |
|---|---|---|---|---|---|---|
| No. of patients | 78 | 38 | 90 | 37 | 60 | — |
| Female/male | 28/50 | 22/16 | 36/54 | 11/26 | 24/36 | NS |
| Female D and male R | 29% | 15% | 34% | 19% | 30% | NS |
| Median age at HSCT, y (range) | 47 (17-64) | 43 (21-60) | 36 (10-57) | 43 (16-66) | 34 (3-66) | .001 |
| Underlying disease | .006 | |||||
| Acute leukemia | 49% | 49% | 49% | 46% | 42% | |
| Chronic leukemia | 14% | 15% | 27% | 30% | 40% | |
| BMF | 1% | 9% | 21% | 0% | 10% | |
| Lymph neopl | 36% | 27% | 3% | 24% | 8% | |
| Early or intermediate disease status at transplantation | 62% | 75% | 83% | 78% | 88% | .001 |
| Type of GI decontamination | .001 | |||||
| None or G- (1) | 100% | — | 100% | 100% | — | |
| G+ and G- (2) | — | 100% | — | — | 100% | |
| Standard therapy | 49% | 56% | 58% | 68% | 81% | .002* |
| RIC | 51% | 44% | 42% | 32% | 19% | — |
| Marrow | 19% | 12% | 65% | 46% | 64% | .001† |
| PBSCs | 81% | 88% | 35% | 54% | 36% | — |
. | Cohort I Center 1 . | Cohort II Center 2 . | Cohort II Center 3 . | Cohort II Center 4 . | Cohort II Center 5 . | P . |
|---|---|---|---|---|---|---|
| No. of patients | 78 | 38 | 90 | 37 | 60 | — |
| Female/male | 28/50 | 22/16 | 36/54 | 11/26 | 24/36 | NS |
| Female D and male R | 29% | 15% | 34% | 19% | 30% | NS |
| Median age at HSCT, y (range) | 47 (17-64) | 43 (21-60) | 36 (10-57) | 43 (16-66) | 34 (3-66) | .001 |
| Underlying disease | .006 | |||||
| Acute leukemia | 49% | 49% | 49% | 46% | 42% | |
| Chronic leukemia | 14% | 15% | 27% | 30% | 40% | |
| BMF | 1% | 9% | 21% | 0% | 10% | |
| Lymph neopl | 36% | 27% | 3% | 24% | 8% | |
| Early or intermediate disease status at transplantation | 62% | 75% | 83% | 78% | 88% | .001 |
| Type of GI decontamination | .001 | |||||
| None or G- (1) | 100% | — | 100% | 100% | — | |
| G+ and G- (2) | — | 100% | — | — | 100% | |
| Standard therapy | 49% | 56% | 58% | 68% | 81% | .002* |
| RIC | 51% | 44% | 42% | 32% | 19% | — |
| Marrow | 19% | 12% | 65% | 46% | 64% | .001† |
| PBSCs | 81% | 88% | 35% | 54% | 36% | — |
No major differences with regard to prophylactic immunosuppression were observed, and T-cell depletion was used only in a minority of patients and centers.
NS indicates not significant; D, donor; R, recipient; BMF, bone marrow failure syndromes (severe aplastic anemia, Fanconi anemia, paroxysmal nocturnal hemoglobinuria); lymph neopl, lymphatic malignancies including non-Hodgkin lymphomas, Hodgkin disease, and myeloma; GI, gastrointestinal; G-, Gram-negative; G+, Gram-positive; and —, not applicable.
Comparison of standard therapy and RIC.
Comparison of marrow and PBSCs.