Page 142 - 2019_06-Haematologica-web

F. Monaco et al.
transplant characteristics are summarized in Table 1. Thirty-six patients were enrolled in Arm A and 41 in Arm B.
Engraftment
Neutrophils declined below 0.5x109/L in 35 out of 36 patients in Arm A and in all patients in Arm B. The cumu- lative incidences of neutrophil recovery at day 28 were 100% in Arm A and 97.4% in Arm B. The median time to
Table 1. Patients’ characteristics.
Sex, n (%) Female Male
Diagnosis, n (%)
Myelofibrosis
Low-risk MDS (MDS-SLD, MDS-MLD, MDS-U, MDS-RS) PNH
High-risk MDS (MDS-EB-1)
CMML
Treatment, n (%)
Dose level 1 (TBI 300 cGy) Dose level 2 (TBI 400 cGy) Dose level 3 (TBI 450 cGy)
Time from diagnosis to HCT, month, median (range)
Age at transplant, years, median (range)
HCT-CI, n (%) 0
neutrophil >0.5x109/L was 13.5 days in Arm A and 13 days in Arm B. The platelet counts did not decline below 20x109/L in 9 out of 36 (25%) patients in Arm A and in 11 out of 41 (26.8%) patients in Arm B. The cumulative inci- dences of platelet recovery (>20x109/L) at day 84 were 97.2% in Arm A and 100% in Arm B. The median times to platelet recovery were 3.5 days in Arm A and 7 days in Arm B. There were two graft failures, both in patients enrolled in Arm A.
1–2
9 (25%) 27 (75%)
18 (50%) 17 (47.2%) 1 (2.8%)
39 (100%)
15.4 (4–336)
65 (37–71) Median 3 (range 0–8)
4 (11.1%) 11 (30.6%) 21 (58.3%)
0 0
16 (44.4%) 18 (50%) 2 (5.6%)
13.5 (0–28) 3.5 (0–107)
3 2
9
14 (34.1%) 27 (65.9%)
28 (68.3%)
13 (31.7%)
12 (39.3%) 5 (12.2%) 24 (58.5%)
8.4 (1–92)
67 (52–74)
Median 3 (range 0–9) 7 (17.1%)
12 (29.3%)
22 (53.6%)
2 2
14 (34.1%) 25 (61%) 2 (4.9%)
13 (2–29) 7 (0–43)
10
15
ARMA(n=36) ARMB(n=41)
≥3
Previous stem-cell transplantation, n Autologous
Allogeneic
Donor, n (%) MRD
URD 10/10 URD 9/10
Neutrophils <0.5×109/L, days, median (range)
Platelets <20×109L, days, median (range)
HCT-failure before day +200, n Relapse
Graft failure
Relapse, n
Death,n 24 31
Cause of death, n
Progression/relapse NRM non-GvHD related
NRM GvHD related
Follow up, months, median (range)
9
6
Pneumonia n = 3 Sepsis n = 1 Disseminated aspergillus n = 1 Suicide n = 1
9
GvHD refractory n = 4 Pneumonia n = 2 Multiorgan failure n = 1 CNS bleeding n = 1 Sepsisn=1
69.1 (39.1–121.8)
15
6 Pneumonia n = 2 Cardiac toxicity n = 2 Multiorgan failure n = 2
10
GvHD refractory n = 3 Pneumonia n = 2 Sepsis n = 4 Disseminated aspergillus n = 1
21 (3.4–102.6)
CMML: chronic myelomonocytic leukemia; CNS: central nervous system; GvHD: graft-versus-host disease; HCT-CI: hematopoietic cell transplantation comorbidity index; MDS: myelodysplastic syndrome; MDS-EB myelodysplastic syndrome with excess of blasts-1; MDS-RS: myelodysplastic syndrome with ring sideroblast; MDS-U: myelodysplastic syndrome unclassifiable; MLD: multilineage dysplasia; MRD: HLA-matched related donor; NRM: non-relapse mortality; PNH: paroxysmal nocturnal hemoglobinuria; SLD: single lineage dysplasia; TBI: total body irradiation; URD: HLA-matched unrelated donor.
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