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Table 1 Patient and donor characteristics

From: Prophylactic NAC promoted hematopoietic reconstitution by improving endothelial cells after haploidentical HSCT: a phase 3, open-label randomized trial

Characteristics Low-risk arm (group C) High-risk arm
NAC prophylaxis cohort (group A) Control cohort (group B)
Number of patients 105 80 40
Median age (range), years 31 (15–55) 31 (15–53) 30 (15–48)
Male gender, N (%) 61 (58.1) 41 (51.3) 27 (67.5)
Diagnosis, N (%)
 AML 57 (54.3) 41 (51.2) 22 (55.0)
  refined disease risk index
   Low (favorable cytogenetics, any CR) 3 (5.3) 6 (14.6) 0
   Intermediate (intermediate cytogenetics, any)CR) 30 (52.6) 21 (51.2) 12 (54.5)
   High (adverse cytogenetics, any CR) 24 (42.1) 14 (34.1) 10 (45.5)
  Remission status
   First CR (CR1) 51 (90.5) 37 (90.2) 22 (100)
   Second CR (CR2) 6 (9.5) 4 (9.8) 0
 ALL 48 (45.7) 39 (48.8) 18 (45.0)
  refined disease risk index
   Intermediate (CR1) 47 (97.9) 37 (94.9) 17 (94.4)
    High (CR2) 1 (2.1) 2 (5.1) 1(5.6)
 Philadelphia positive 15 (31.3) 11 (28.2) 6 (33.3)
Measurable residual disease before transplant, N (%)
 Negative 65 (61.9) 53 (66.2) 23 (57.5)
 Positive 40 (38.1) 27 (33.8) 17 (42.5)
Median time from diagnosis to HSCT(range), months 5 (3–24) 5 (2–42) 5 (3–12)
Median donor age(range), years 40 (10–64) 45 (10–66) 37 (8–61)
HLA-A, B, DR mismatched grafts, N (%)
 1 5 (4.8) 2 (2.4) 1 (2.5)
 2 21 (20.0) 15 (18.8) 5 (12.5)
 3 79 (75.2) 63 (78.8) 34 (85.0)
Donor-recipient gender matched, N (%)
 Male-male 43 (41.0) 31 (38.8) 20 (50.0)
 Male-female 29 (27.6) 30 (37.5) 11 (27.5)
 Female-male 18 (17.1) 10 (12.5) 7 (17.5)
 Female-female 15 (14.3) 9 (11.2) 2 (5.0)
Donor-recipient relationship, N (%)
 Father-child 37 (35.2) 42 (52.5) 18 (45.0)
 Mother-child 11 (10.5) 4 (5.0) 2 (5.0)
 Sibling-sibling 23 (21.9) 12 (15.0) 7 (17.5)
 Child-parent 30 (28.6) 19 (23.8) 13 (32.5)
 Collateral relatives 4 (3.8) 3 (3.8) 0
ABO matched grafts, N (%)
 Matched 50 (47.6) 43 (53.8) 23 (57.5)
 Major mismatch 22 (21.0) 17 (21.3) 5 (12.5)
 Minor mismatch 25 (23.8) 15 (18.8) 10 (25.0)
 Bi-directional mismatch 8 (7.6) 5 (6.3) 2 (5.0)
Median chemo cycles pre-HSCT (range) 3 (2–9) 3 (2–12) 3 (2–14)
≥2 Induction cycles to achieve CR, N (%) 18 (17.1) 16 (20.0) 9 (22.5)
Median CD34+ cells, 106/kg (range) 2.86 (0.77–14.10) 3.15 (0.49–9.42) 3.31 (0.92–7.45)
  1. Abbreviations: NAC N-acetyl-L-cysteine, AML Acute myeloid leukemia, ALL Acute lymphoblastic leukemia, HLA Human leukocyte antigen, HSCT Hematopoietic stem cell transplantation, chemo chemotherapy, CR Complete remission