Table 1:
Baseline characteristics for clinical trial patients by conditioning intensity
| Characteristic | MAC | RIC | Total |
|---|---|---|---|
|
| |||
| No. of patients | 40 | 40 | 80 |
| No. of centers | 9 | 8 | 11 |
| HIV infection pre-HCT - no. (%) | |||
| No | 40 | 36 (90) | 76 (95) |
| Yes | 0 | 4 (10) | 4 (5) |
| Age at HCT, years - no. (%) | |||
| Median (min-max) | 48.5 (18–66) | 59.5 (23–70) | 51.5 (18–70) |
| 15–29 | 8 (20) | 3 (7.5) | 11 (13.8) |
| 30–49 | 13 (32.5) | 11 (27.5) | 24 (30) |
| 50–70 | 19 (47.5) | 26 (65) | 45 (56.3) |
| Sex - no. (%) | |||
| Male | 23 (58) | 19 (48) | 42 (53) |
| Female | 17 (43) | 21 (53) | 38 (48) |
| Race - no. (%) | |||
| American Indian or Alaska Native | 1 (3) | 0 | 1 (1) |
| Asian | 1 (3) | 1 (3) | 2 (3) |
| Black or African American | 9 (23) | 6 (15) | 15 (19) |
| White | 29 (73) | 31 (78) | 60 (75) |
| Not reported/unknown | 0 | 2 (5) | 2 (3) |
| Ethnicity - no. (%) | |||
| Hispanic or Latino | 12 (30) | 7 (18) | 19 (24) |
| Not Hispanic or Latino | 28 (70) | 33 (83) | 61 (76) |
| Race/ethnicity - no. (%) | |||
| White/non-Hispanic | 17 (43) | 25 (63) | 42 (53) |
| Others | 23 (58) | 15 (38) | 38 (48) |
| Karnofsky score - no. (%) | |||
| 70 | 2 (5) | 1 (3) | 3 (4) |
| 80 | 12 (30) | 12 (30) | 24 (30) |
| 90 | 21 (53) | 17 (43) | 38 (48) |
| 100 | 5 (13) | 10 (25) | 15 (19) |
| HCT-CI - no. (%) | |||
| 0 | 4 (10) | 9 (23) | 13 (16) |
| 1 | 2 (5) | 8 (20) | 10 (13) |
| 2 | 10 (25) | 4 (10) | 14 (18) |
| 3+ | 24 (60) | 19 (48) | 43 (54) |
| Disease status at HCT - no. (%) | |||
| AML | 23 (57.5) | 14 (35) | 37 (46.3) |
| CR1 | 22 | 10 | 32 |
| CR2+ | 1 | 2 | 3 |
| PIF | 0 | 2 | 2 |
| ALL | 10 (25) | 7 (17.5) | 17 (21.3) |
| CR1 | 7 | 6 | 13 |
| CR2+ | 3 | 1 | 4 |
| CLL | 0 | 3 (7.5) | 3 (3.8) |
| CR | 0 | 3 | 3 |
| MDS | 2 (5) | 0 | 2 (2.5) |
| CR | 1 | 0 | 1 |
| HI | 1 | 0 | 1 |
| Other acute leukemia | 4 (10) | 0 | 4 (5) |
| CR1 | 3 | 0 | 3 |
| CR2+ | 1 | 0 | 1 |
| NHL | 1 (2.5) | 11 (27.5) | 12 (15) |
| CR1 | 0 | 5 | 5 |
| CR2+ | 1 | 3 | 4 |
| Relapse | 0 | 2 | 2 |
| PIF | 0 | 1 | 1 |
| HL | 0 | 5 (12.5) | 5 (6.3) |
| CR1 | 0 | 2 | 2 |
| Relapse | 0 | 1 | 1 |
| PIF | 0 | 2 | 2 |
| Refined disease risk index - no. (%) | |||
| Low | 3 (8) | 6 (15) | 9 (11) |
| Intermediate | 29 (73) | 21 (53) | 50 (63) |
| High | 3 (8) | 7 (18) | 10 (13) |
| Very high | 0 | 3 (8) | 3 (4) |
| N/A | 5 (13) | 3 (8) | 8 (10) |
| CMV serostatus - no. (%) | |||
| Negative | 16 (40) | 18 (45) | 34 (43) |
| Positive | 24 (60) | 22 (55) | 46 (58) |
| Time between diagnosis to HCT - no. (%) | |||
| < 6 months | 14 (35) | 10 (25) | 24 (30) |
| >= 6 months | 26 (65) | 30 (75) | 56 (70) |
| Number of prior auto HCTs - no. (%) | |||
| 0 | 38 (95) | 37 (93) | 75 (94) |
| 1 | 2 (5) | 3 (8) | 5 (6) |
| Infused total nucleated cells, ×108/kg - median (min-max) | 2.81 (0.6–520.8) | 2.8 (0.76–5.8) | 2.8 (0.76–520.8) |
| Infused CD34+ cells, ×106/kg - median (min-max) | 2.72 (0.89–5.24) | 2.2 (0.39–6.23) | 2.66 (0.39–6.23) |
| Conditioning regimen - no. (%) | |||
| TBI/Cy/Flu | 0 | 40 | 40 (50) |
| Bu/Cy | 3 (8) | 0 | 3 (4) |
| Bu/Flu | 31 (78) | 0 | 31 (39) |
| TBI/Cy | 6 (15) | 0 | 6 (8) |
| HLA match - no. (%) | |||
| 7/8 | 26 (65) | 23 (58) | 49 (61) |
| 6/8 | 8 (20) | 11 (28) | 19 (24) |
| 5/8 | 5 (13) | 2 (5) | 7 (9) |
| 4/8 | 1 (3) | 4 (10) | 5 (6) |
| Donor age, years - no. (%) | |||
| Median (min-max) | 27 (18–56) | 29 (21–44) | 29 (18–56) |
| 18–29 | 24 (60) | 23 (58) | 47 (59) |
| 30–39 | 9 (23) | 11 (28) | 20 (25) |
| 40–49 | 4 (10) | 6 (15) | 10 (13) |
| 50–59 | 3 (8) | 0 | 3 (4) |
| Donor weight, kg - median (min-max) | 77 (55–103) | 77 (52–104) | 77 (52–104) |
| Donor sex - no. (%) | |||
| Male | 20 (50) | 24 (60) | 44 (55) |
| Female | 20 (50) | 16 (40) | 36 (45) |
| Donor/recipient sex - no. (%) | |||
| M-M | 12 (30) | 12 (30) | 24 (30) |
| M-F | 8 (20) | 12 (30) | 20 (25) |
| F-M | 11 (28) | 7 (18) | 18 (23) |
| F-F | 9 (23) | 9 (23) | 18 (23) |
| Donor/recipient CMV serostatus - no. (%) | |||
| +/+ | 16 (40) | 13 (33) | 29 (36) |
| +/− | 8 (20) | 7 (18) | 15 (19) |
| −/+ | 8 (20) | 9 (23) | 17 (21) |
| −/− | 8 (20) | 11 (28) | 19 (24) |
| Donor/recipient ABO match - no. (%) | |||
| Matched | 20 (50) | 24 (60) | 44 (55) |
| Minor mis-match | 12 (30) | 5 (13) | 17 (21) |
| Major mis-match | 8 (20) | 8 (20) | 16 (20) |
| Bi-directional |
0 | 3 (8) | 3 (4) |