Table 1.
Patient, disease, and treatment characteristics.
| Variable | N (%) |
|---|---|
| Cohort Size, Overall | 775 |
| Transplant Indication | |
| Myeloid malignancies | 520 (67.1) |
| AML/MDS | 408 |
| Myeloproliferative and MDS/MPN overlap neoplasia | 112 |
| Lymphoid malignancies | 228 (29.4) |
| ALL, including lymphoblastic lymphoma | 110 |
| Lymphoma, including CLL | 77 |
| Myeloma | 41 |
| Non-malignant disorders | 27 (3.5) |
| Disease Stage at Transplant | |
| Early/low-risk | 288 (37.2) |
| Intermediate or advanced/high-risk | 487 (62.8) |
| Conditioning Regimen | |
| Myeloablative (including reduced toxicity myeloablative) * | 527 (68.0) |
| Reduced intensity or non-myeloablative ** | 248 (32.0) |
| Donor Type | |
| Sibling | 393 (50.7) |
| HLA matched | 388 |
| 1 Ag mismatched | 5 |
| Unrelated | 382 (49.3) |
| HLA matched (10/10 or 12/12 including DRB3-5) | 246 |
| HLA mismatched | 136 |
| Graft Source | |
| Bone marrow | 143 (18.5) |
| Peripheral blood (G-CSF mobilized) | 632 (81.5) |
| Incorporation of ATG | |
| No | 425 (54.8) |
| Yes | 350 (45.2) |
| ATG-Fresenius (Grafalon, Neovii) | 256 |
| Lower dose *** | 160 |
| Higher dose *** | 96 |
| Thymoglobuline | 87 |
| Lower dose *** | 71 |
| Higher dose *** | 16 |
| Alemtuzumab *** | 7 (0.9) |
| Post-grafting Immunosuppression | |
| MTX-based (mainly CsA/MTX) | 340 (43.9) |
| MTX-free (mainly CsA/MMF) | 435 (56.1) |
| HLA-C KIR-L Status | |
| C1/1 | 291 (37.5) |
| C1/2 | 363 (46.9) |
| C2/2 | 121 (15.6) |
* Myeloablative conditioning (MAC) regimens included full intensity MAC (total body irradiation (TBI) 10–13.2 Gy plus high-dose cyclophosphamide ± etoposide, or busulfan 12.8 mg/kg i.v. (or equivalent oral dose) plus high-dose cyclophosphamide ± etoposide), or reduced toxicity myeloablative conditioning (RTC, fludarabine plus i.v. busulfan 9.6–12.8 mg/kg ± thiotepa, or fludarabine plus 8.25–10 Gy TBI). ** Reduced intensity conditioning (RIC) included fludarabine plus either 4 Gy TBI or i.v. busulfan 6.4 mg/kg ± thiotepa. Non-myeloablative (NMA) regimen included fludarabine ± cyclophosphamide ± a maximum dose of either 2 Gy TBI or i.v. busulfan 3.2 mg/kg. In patients with refractory acute leukemia, the preparative regimen was intensified either by the addition of etoposide or thiotepa, or by application of a sequential protocol consisting of a 4-day FLAC (fludarabine, cytarabine) or FLAMSA (fludarabine, cytarabine ± amsacrine) induction phase followed after a 3-day rest by a TBI- or busulfan-based RIC or RTC. *** For anti-thymocyte globulin (ATG)-F, a lower dose was defined as ≤30 mg/kg total, and higher doses were those ≥35 mg/kg total. For Thymoglobuline, a lower dose was defined as ≤5 mg/kg total, and higher doses were those ≥7.5 mg/kg total. Alemtuzumab was dosed 40–100 mg flat (independent of bodyweight), with a median dose of 50 mg. All alemtuzumab doses were assigned to the higher-dose serotherapy group. HLA: human leukocyte antigen; AML, acute myeloid leukemia; MDS, myelodysplastic syndromes; ALL, acute lymphoblastic leukemia; CLL, chronic lymphocytic leukemia; MTX, methotrexate