Table 1.
Patient characteristics ATG-Genzyme and ATG-Fresenius groups.
| ATG Genzyme | ATG Fresenius | p-value | |
|---|---|---|---|
| Number of patients | 42 | 16 | |
| TRANSPLANT CENTER, n (%) | |||
| Leiden | 38 (90) | ||
| Copenhagen | 4 (10) | 16 (100) | |
| Patient age, years; median (range) | 9 (1–18) | 6 (1–17) | 0.248 |
| DIAGNOSIS, n (%) | |||
| Acute lymphoblastic leukemia | 17 (40) | 16 (100) | <0.001 |
| Acute myeloid leukemia | 25 (60) | – | |
| DONOR, n (%) | |||
| HLA match 10/10 | 30 (71) | 13 (81) | 0.52 |
| HLA match 8–9/10 | 12 (29) | 3 (19) | |
| STEM CELL SOURCE, n (%) | |||
| Bone marrow | 34 (81) | 14 (87) | 0.71 |
| Peripheral blood | 8 (19) | 2 (13) | |
| TOTAL NC DOSE, 108/kg BW; median (range) | |||
| Bone marrow graft | 2.8 (0.6–9.6) | 5.5 (2.3–7.9) | 0.02 |
| Peripheral blood graft | 8.3 (5.0–16.4) | 16.1* | – |
| SEROTHERAPY ATG, mean (range) | |||
| Genzyme; mg/kg BW | 8.7 (6.0–10.5) | – | – |
| Fresenius; mg/kg BW | – | 53 (45–60) | |
| SEROTHERAPY PARAMETERS, median (range) | |||
| Start serotherapy, day pre-HSCT | −6 (−8 to −3) | −4 (−7 to −3) | <0.001 |
| Days ATG infusion | 3 to 4 | 3 | <0.001 |
| Bodyweight, kg | 35 (9 to 84) | 25 (9 to 69) | 0.141 |
| Lymphocytes pre-ATG, × 109/L | 0.2 (0.01 to 1.2) | 0.05 (0.01 to 0.7) | 0.10 |
| CONDITIONING REGIMEN, n (%) | |||
| Chemotherapy + TBI | 6 (14) | 9 (56) | 0.002 |
| Chemotherapy | 36 (86) | 7 (44) | |
| GvHD PROPHYLAXIS, n (%) | |||
| CSA + MTX | 36 (86) | 16 (100) | 0.04 |
| MTX + tacrolimus | 1 (2) | ||
| CSA + MTX + MMF | 5 (12) | ||
| PATIENTS AT RISK†, n (%) | |||
| CMV | 29 (69) | 14 (87) | 0.19 |
| EBV | 41 (98) | 13 (100)* | 1.00 |
BW, body weight; CMV, cytomegalovirus; CsA, cyclosporine A; EBV, Epstein-Barr virus; MTX, methotrexate; MMF, mycofenolate mofetil; NC, nucleated cells; TBI, total body irradiation.
*
Data of 1 patient (NC dose) and data of the EBV status of 3 donor-patients couples pre-conditioning were lacking.
†
CMV and EBV seropositive patients and seronegative patients with a seropositive donor.