TABLE 2.
Transplantation Outcomes
| Outcome | HAPLO Arm, n = 60 |
9/10 MUD Arm, n = 46 |
|---|---|---|
| Engraftment, % | 97 | 98 |
| Median time to platelet recovery, d | 25 | 28 |
| Median time to ANC >500/μL, d | 18 | 18 |
| Chimerism at day 30 excluding patients with graft failure or early death, no./no. evaluable | ||
| Full | 56/57 | 43/44 |
| Mixed | 1/57 | 1/44 |
| OS rate [95% CI], % | ||
| Day 100 | 90 [79–95] | 87 [73–94] |
| 1 y | 70 [55–79] | 60 [44–73] |
| 2 y | 55 [40–67] | 52 [35–65] |
| PFS rate [95% CI], % | ||
| Day 100 | 88 [77–94] | 80 [66–89] |
| 1 y | 60 [46–72] | 47 [32–61] |
| 2 y | 53 [38–65] | 42 [27–55] |
| Relapse cumulative incidence [95% CI], % | ||
| Day 100 | 2 [0.1–8] | 7 [2–16] |
| 1 y | 19 [10–31] | 25 [13–38] |
| 2 y | 24 [14–37] | 25 [13–38] |
| Grade II–IV aGVHD cumulative incidence [95% CI], % | ||
| Day 100 | 28 [18–40] | 33 [20–46] |
| 1 y | 33 [22–45] | 40 [25–54] |
| Grade III–IV aGVHD cumulative incidence [95% CI], % | ||
| Day 100 | 3 [0 6–10] | 13 [5–25] |
| 1 y | 5 [1–13] | 15 [7–27] |
| cGVHD cumulative incidence [95% CI], % | ||
| 1 y | 19 [10–30] | 19 [9–32] |
| 2 y | 24 [13–36] | 19 [9–32] |
| NRM cumulative incidence [95% CI], % | ||
| Day 100 | 10 [4–19] | 13 [5–25] |
| 1 y | 21 [11–32] | 31 [18–45] |
| 2 y | 23 [13–35] | 34 [20–48] |
| CMV reactivation cumulative incidence at day 100 [95% CI], % | 66 [52–76] | 67 [50–79] |
| Deaths, no. of patients (%) | 24 (100) | 23 (100) |
| Disease relapse | 11 (46) | 8 (35) |
| Infection | 4 (17) | 5 (22) |
| Organ damage | 4 (17) | 2 (9) |
| aGVHD | 1 (4) | 5 (22) |
| cGVHD | 2 (8) | 2 (9) |
| Graft failure | 2 (8) | 1 (4) |
Abbreviations: 9/10 MUD, HLA-mismatched unrelated donor; aGVHD, acute graft-versus-host disease; ANC, absolute neutrophil count; cGVHD, chronic graft-versus-host disease; CI, confidence interval; CMV, cytomegalovirus; NRM, nonrelapse mortality; OS, overall survival; PFS, progression-free survival.