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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