Table 1.
Clinical and demographic characteristics
| Characteristics | Overall | HHV-6B cohort* | ||
|---|---|---|---|---|
| Brincidofovir (n = 303) | Placebo (n = 149) | Brincidofovir (n = 92) | Placebo (n = 61) | |
| Age in years, median (range) | 56 (18-77) | 54 (20-75) | 57 (18-76) | 59 (20-73) |
| Sex, n (%) | ||||
| Male | 163 (53.8) | 98 (65.8) | 57 (62.0) | 41 (67.2) |
| Female | 140 (46.2) | 51 (34.2) | 35 (38.0) | 20 (32.8) |
| Race, n (%) | ||||
| White | 255 (84.2) | 123 (82.6) | 76 (82.6) | 52 (85.2) |
| African American | 24 (7.9) | 14 (9.4) | 8 (8.7) | 4 (6.6) |
| Asian | 17 (5.6) | 10 (6.7) | 7 (7.6) | 4 (6.6) |
| Other | 7 (2.3) | 2 (1.3) | 1 (1.1) | 1 (1.6) |
| Underlying disease, n (%) | ||||
| Acute myelogenous leukemia | 129 (42.6) | 64 (43.0) | 37 (40.2) | 26 (42.6) |
| Myelodysplasia | 52 (17.2) | 24 (16.1) | 17 (18.5) | 13 (21.3) |
| Non-Hodgkin’s lymphoma | 28 (9.2) | 18 (12.1) | 9 (9.8) | 6 (9.8) |
| Acute lymphocytic leukemia | 29 (9.6) | 13 (8.7) | 6 (6.5) | 6 (9.8) |
| Other | 65 (21.5) | 30 (20.1) | 23 (25.0) | 10 (16.4) |
| Conditioning regimen, n (%) | ||||
| Myeloablative | 162 (53.5) | 86 (57.7) | 40 (43.5) | 32 (52.5) |
| Nonmyeloablative | 141 (46.5) | 63 (42.3) | 52 (56.5) | 29 (47.5) |
| Alemtuzumab use, n (%) | 26 (8.6) | 12 (8.1) | 10 (10.9) | 4 (6.6) |
| Antithymocyte globulin use, n (%) | 85 (28.1) | 47 (31.5) | 30 (32.6) | 18 (29.5) |
| Ex vivo T-cell depletion, n (%) | 36 (11.9) | 20 (13.4) | 13 (14.1) | 6 (9.8) |
| Graft source, n (%) | ||||
| Bone marrow | 41 (13.5) | 24 (16.1) | 13 (14.1) | 10 (16.4) |
| Peripheral blood | 241 (79.5) | 113 (75.8) | 73 (79.3) | 48 (78.7) |
| Cord blood | 19 (6.3) | 11 (7.4) | 6 (6.5) | 3 (4.9) |
| Other† | 2 (0.7) | 1 (0.7) | 0 | 0 |
| Donor type, n (%) | ||||
| Haploidentical | 14 (4.6) | 8 (5.4) | 6 (6.5) | 2 (3.3) |
| Matched related | 97 (32.0) | 52 (34.9) | 29 (31.5) | 26 (42.6) |
| Matched unrelated | 148 (48.8) | 62 (41.6) | 45 (48.9) | 23 (37.7) |
| Mismatched | 34 (11.2) | 27 (18.1) | 12 (13.0) | 10 (16.4) |
| Days from transplant to first dose, n (%) | ||||
| ≤1 weeks | 63 (20.8) | 32 (21.5) | 37 (40.2) | 26 (42.6) |
| >1 to ≤2 weeks | 85 (28.1) | 43 (28.9) | 55 (59.8) | 35 (57.4) |
| >2 to ≤3 weeks | 84 (27.7) | 37 (24.8) | 0 | 0 |
| >3 to ≤4 weeks | 69 (22.8) | 36 (24.2) | 0 | 0 |
| >4 weeks | 2 (0.7) | 1 (0.7) | 0 | 0 |
| Risk category | ||||
| High-risk | 223 (73.6) | 109 (73.2) | 69 (75) | 39 (63.9) |
| Low-risk | 80 (26.4) | 40 (26.8) | 23 (25) | 22 (36.1) |
Data are presented as number (%) unless otherwise indicated.
*
162 patients were randomly assigned within 2 weeks of HCT, received at least 6 doses of brincidofovir or placebo within the first 3 weeks after randomization, and had a baseline sample available (n = 98, brincidofovir; n = 64, placebo); 7 patients had HHV-6B detected in plasma at baseline and were excluded (n = 4, brincidofovir; n = 3, placebo); 2 patients in the brincidofovir group were negative at baseline but had no subsequent samples (supplemental Figure 1).
†
Combination of adult haploidentical peripheral blood and cord blood grafts.