Characteristics of the 178 patients completing follow-up
| Parameter . | Randomization arm . | |
|---|---|---|
| DNAemia . | Antigenemia . | |
| Median age, y (range) | 9 (0-25) | 9 (0-24) |
| Sex, no. male patients/no. female patients | 43/46 | 55/34 |
| Diagnosis, no. patients (%) | ||
| Acute myeloid leukemia | 8 (9) | 13 (14) |
| Acute lymphoblastic leukemia | 24 (27) | 26 (29) |
| Chronic myeloid leukemia | 1 (1) | 0 (0) |
| Myelodysplastic syndrome | 10 (11) | 4 (5) |
| Non-Hodgkin lymphoma | 4 (5) | 1 (1) |
| Hemophagocytic lymphohistiocytosis | 1 (1) | 3 (3) |
| Hemoglobinopathies | 24 (27) | 30 (34) |
| Bone marrow failure | 11 (12) | 5 (6) |
| Inborn metabolism disorders | 4 (5) | 4 (5) |
| Other* | 2 (2) | 3 (3) |
| HCMV serology, no. patients (%) | ||
| R+/D− | 27 (30) | 30 (34) |
| R+/D+ | 50 (56) | 39 (44) |
| R−/D+ | 12 (14) | 20 (22) |
| Donor type, no. patients (%) | ||
| Sibling | 41 (46) | 39 (44) |
| Unrelated | 48 (54) | 50 (56) |
| Source of stem-cell graft, no. patients (%) | ||
| Bone marrow | 80 (90) | 74 (84) |
| Peripheral blood | 2 (2) | 3 (3) |
| Cord blood | 3 (3) | 9 (10) |
| Bone marrow + cord blood | 4 (5) | 3 (3) |
| Conditioning regimen, no. patients (%) | ||
| Chemotherapy based | 61 (68) | 60 (67) |
| TBI based | 28 (32) | 29 (33) |
| ATG administration | 45 (51) | 46 (52) |
| GvHD prophylaxis, no. patients (%) | ||
| Cyclosporine-A | 22 (25) | 25 (28) |
| Cyclosporine-A + methotrexate | 67 (75) | 64 (72) |
| Days to PMN recovery†, median (range) | 20 (8-39) | 20 (9-45) |
| Days to PLT recovery‡, median (range) | 23 (8-95) | 25 (11-195) |
| Grade II-IV acute GvHD | 24 (27) | 26 (29) |
| Chronic GvHD | 7 (8) | 6 (7) |
| Parameter . | Randomization arm . | |
|---|---|---|
| DNAemia . | Antigenemia . | |
| Median age, y (range) | 9 (0-25) | 9 (0-24) |
| Sex, no. male patients/no. female patients | 43/46 | 55/34 |
| Diagnosis, no. patients (%) | ||
| Acute myeloid leukemia | 8 (9) | 13 (14) |
| Acute lymphoblastic leukemia | 24 (27) | 26 (29) |
| Chronic myeloid leukemia | 1 (1) | 0 (0) |
| Myelodysplastic syndrome | 10 (11) | 4 (5) |
| Non-Hodgkin lymphoma | 4 (5) | 1 (1) |
| Hemophagocytic lymphohistiocytosis | 1 (1) | 3 (3) |
| Hemoglobinopathies | 24 (27) | 30 (34) |
| Bone marrow failure | 11 (12) | 5 (6) |
| Inborn metabolism disorders | 4 (5) | 4 (5) |
| Other* | 2 (2) | 3 (3) |
| HCMV serology, no. patients (%) | ||
| R+/D− | 27 (30) | 30 (34) |
| R+/D+ | 50 (56) | 39 (44) |
| R−/D+ | 12 (14) | 20 (22) |
| Donor type, no. patients (%) | ||
| Sibling | 41 (46) | 39 (44) |
| Unrelated | 48 (54) | 50 (56) |
| Source of stem-cell graft, no. patients (%) | ||
| Bone marrow | 80 (90) | 74 (84) |
| Peripheral blood | 2 (2) | 3 (3) |
| Cord blood | 3 (3) | 9 (10) |
| Bone marrow + cord blood | 4 (5) | 3 (3) |
| Conditioning regimen, no. patients (%) | ||
| Chemotherapy based | 61 (68) | 60 (67) |
| TBI based | 28 (32) | 29 (33) |
| ATG administration | 45 (51) | 46 (52) |
| GvHD prophylaxis, no. patients (%) | ||
| Cyclosporine-A | 22 (25) | 25 (28) |
| Cyclosporine-A + methotrexate | 67 (75) | 64 (72) |
| Days to PMN recovery†, median (range) | 20 (8-39) | 20 (9-45) |
| Days to PLT recovery‡, median (range) | 23 (8-95) | 25 (11-195) |
| Grade II-IV acute GvHD | 24 (27) | 26 (29) |
| Chronic GvHD | 7 (8) | 6 (7) |
All P values were nonsignificant.
R indicates recipient; D, donor; TBI, total body irradiation; ATG, anti-thymocyte globulin; GvHD, graft-versus-host disease; PMN, polymorphonuclear; PLT, platelet; ns; not significant.
Other includes 1 congenital sideroblastic anemia, 1 metastatic renal cell carcinoma, 1 Chediak-Higashi syndrome, 1 IPEX (immune dysregulation, polyendocrinopathy, enteropathy, X-linked), 1 Kostmann syndrome.
Defined as time needed to reach an absolute neutrophil count equal to or greater than 0.5 × 109/L.
Defined as time needed to reach an unsupported platelet count equal to or greater than 50 ×109/L.