Table 1.
Characteristics of allotransplant patients with BM EC < 0.1% or EC ≥ 0.1% pre-HSCT
| Characteristics | 1EC < 0.1%, N = 30 | 1EC ≥ 0.1%, N = 38 | P* | 2EC < 0.1% + NAC, N = 35 | 2EC ≥ 0.1%, N = 39 | P† | P‡ |
|---|---|---|---|---|---|---|---|
| BM ECs pre-HSCT, median (range), % | 0.04 (0.01-0.09) | 0.2 (0.1-0.6) | <.0001 | 0.05 (0.01-0.08) | 0.2 (0.1-0.7) | <.0001 | .36 |
| Blood cell count at +2 mo post-HSCT, median (range) | |||||||
| WBC, ×109/L | 3.2 (1.2-8.3) | 5.1 (1.7-10.7) | .04 | 3.75 (1.4-9.8) | 3.6 (2.1-11.3) | .59 | .67 |
| ANC, ×109/L | 1.5 (0.6-5.1) | 2.2 (0.7-9) | .04 | 1.8 (0.7-8.8) | 1.9 (0.8-7.4) | .95 | .18 |
| Hb, g/L | 90 (61-132) | 99 (69-137) | .13 | 96 (70-137) | 97 (63-124) | .67 | .24 |
| PLT, ×109/L | 39 (13-142) | 72 (28-262) | .04 | 79 (45-175) | 78 (42-196) | .83 | .005 |
| Age at HSCT, median (range), y | 32 (16-52) | 33 (18-58) | .66 | 31 (16-54) | 32 (18-55) | .21 | .42 |
| Sex, male/female | 15/15 | 22/16 | .63 | 17/18 | 17/22 | .82 | 1.00 |
| Underlying disease, n | .81 | 1.00 | .81 | ||||
| AML | 16 | 22 | 17 | 20 | |||
| ALL | 14 | 16 | 18 | 19 | |||
| Status at HSCT, n | 1.00 | .81 | 1.00 | ||||
| Standard-risk | 20 | 26 | 23 | 27 | |||
| High-risk | 10 | 12 | 12 | 12 | |||
| HCT-CI pre-HSCT score | .43 | .91 | .65 | ||||
| 0-2 | 29 | 35 | 33 | 37 | |||
| ≥3 | 1 | 3 | 2 | 2 | |||
| Source of stem cell | 1.00 | 1.00 | 1.00 | ||||
| BM and PB, n | 30 | 38 | 35 | 39 | |||
| Transplanted total nucleated cell dose, median (range), ×108/kg | 7.9 (6.6-12.4) | 8.1 (6.3-10.5) | .85 | 8.2 (6.5-12.4) | 8.2 (5.6-11.5) | .13 | .55 |
| Transplanted CD34+ cell dose, median (range), ×106/kg | 2.8 (1.6-4.3) | 3.1 (1.1-4.5) | .38 | 3.0 (1.9-4.2) | 2.8 (1.1-4.1) | .55 | .82 |
| Donor match, n | .60 | 1.00 | .79 | ||||
| HLA ≤3 locus matched related donor | 22 | 25 | 24 | 27 | |||
| HLA >3 locus matched related donor | 8 | 13 | 11 | 12 | |||
| Sex mismatch, n | |||||||
| Female to male | 3 | 7 | .49 | 5 | 3 | .46 | .72 |
| Female to female | 3 | 6 | .72 | 4 | 6 | 1.00 | 1.00 |
| Male to female | 15 | 10 | .08 | 14 | 16 | .50 | .33 |
| Male to male | 9 | 15 | .45 | 12 | 14 | 1.00 | .79 |
| ABO mismatch, n | |||||||
| No | 16 | 27 | .21 | 20 | 23 | 1.00 | .81 |
| Minor | 9 | 4 | .06 | 5 | 6 | 1.00 | .14 |
| Major | 5 | 7 | 1.00 | 10 | 10 | .80 | .38 |
| Pre-HSCT cycles of chemotherapy, n (range) | 4 (0-7) | 4 (3-8) | .11 | 4 (2-7) | 4 (3-8) | .08 | .49 |
| Conditioning | 1.00 | 1.00 | 1.00 | ||||
| BU/CY + ATG, n | 30 | 38 | 35 | 39 | |||
| aGVHD post-HSCT, n | 14 | 10 | .12 | 14 | 16 | 1.00 | .62 |
| Onset of aGVHD post-HSCT, median (range), d | 24.5 (16-63) | 23.5 (15-52) | .34 | 25 (17-59) | 25 (15-57) | .28 | .87 |
| aGVHD treatment, n | .94 | .87 | 1.00 | ||||
| Steroid | 10 | 7 | 10 | 11 | |||
| Second- or third-line therapy | 4 | 3 | 4 | 5 | |||
| TMA post-HSCT | 0 | 1 | 1.00 | 0 | 1 | 1.00 | 1.00 |
| Onset of TMA post-HSCT, d | 145 | 90 | |||||
| CMV reactivation post-HSCT, n | 24 | 21 | .04 | 26 | 22 | .14 | .77 |
| Onset of CMV reactivation post-HSCT, median (range), d | 35 (20-52) | 36 (22-51) | .56 | 35 (26-52) | 36 (27-54) | .49 | .79 |
| CMV reactivation treated with ganciclovir, n | 18 | 16 | .22 | 20 | 16 | .24 | .82 |
| G-CSF administration post-HSCT, median (range), μg | 5 012 (1 900-12 850) | 3425 (1600-7750) | <.0001 | 3700 (1600-7450) | 3700 (1600-8750) | .51 | .008 |
| Transfusion of PLT post-HSCT, median (range), U | 9.5 (1-36) | 4 (0-10) | <.0001 | 6 (0-18) | 7 (0-20) | .35 | <.0001 |
| Transfusion of RBC post-HSCT, median (range), U | 8 (0-20) | 4 (0-12) | <.0001 | 2 (0-22) | 4 (0-18) | .77 | .04 |
The characteristics of allotransplant patients with BM EC < 0.1% or EC ≥ 0.1% pre-HSCT enrolled in the 2 clinical trials (NCT02978274 and NCT03236220) are shown in the table. The first trial included 2 groups of patients with 1EC < 0.1% (N = 30) and 1EC ≥ 0.1% (N = 38) enrolled from March 2016 to March 2017. The second trial included 2 groups of patients with 2EC < 0.1% + NAC (N = 35) and 2EC ≥ 0.1% (N = 39) enrolled from August 2017 to June 2018. The continuous variables were compared using the Mann-Whitney U test, and the differences in frequency between the 2 groups were compared using the χ2 test. The criterion for statistical significance was P < .05.
ALL, acute lymphocytic leukemia; AML, acute myelogenous leukemia; ATG, antithymocyte globulin; BU/CY, busulfan/cyclophosphamide; Hb, hemoglobin; PB, peripheral blood; PLT, platelet; RBC, red blood count; TMA, thrombotic microangiopathy; WBC, white blood cell.
The P values present the comparison between the 1EC < 0.1% (N = 30) and 1EC ≥ 0.1% (N = 38) groups.
The P values present the comparison between the 2EC < 0.1% + NAC (N = 35) and 2EC ≥ 0.1% (N = 39) groups.
The P values present the comparison between the 1EC < 0.1% (N = 30) and 2EC < 0.1% + NAC (N = 35) groups.