Skip to main content

Table 1 Baseline, disease, transplantation and GVHD characteristics of patients with SR aGVHD in two groups

From: Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3, open-label trial

Variable

MSC group

No. (%)

Control group

No. (%)

P

No. of patients

99

99

 

Age, median (range), years

28 (16–59)

29 (16–57)

0.680

 < 18 year

14

17

 

 ≥ 18 year

85

82

 

Sex

  

0.385

 Male

62 (62.6%)

56 (56.6%)

 

 Female

37 (37.4%)

43 (43.4%)

 

Disease

  

0.129

 AML

39 (39.4%)

49 (49.5%)

 

 ALL

45 (45.5%)

43 (43.4%)

 

 Others*

15 (15.2%)

7 (7.1%)

 

  MDS

6 (6.1%)

3 (3.0%)

 

  CML

3 (3.0%)

1 (1.0%)

 

  MM

1 (1.0%)

0

 

  NHL

0

1 (1.0%)

 

  Other acute leukemia

5 (5.1%)

2 (2.0%)

 

Disease status at transplant

  

0.524

 CR

63 (63.6%)

70 (70.7%)

 

 PR

6 (6.1%)

6 (6.1%)

 

 NR

30 (30.3%)

23 (23.2%)

 

HLA typing

  

1.000

 HLA matched

51 (51.5%)

51 (51.5%)

 

 HLA mismatched

48 (48.5%)

48 (48.5%)

 

Conditioning

  

0.200

 Bu-based

51 (51.5%)

42 (42.4%)

 

 TBI-based

48 (48.5%)

57 (57.6%)

 

Donor source

  

0.567

 PBSC

53 (53.5%)

57 (57.6%)

 

 PBSC + BM

46 (46.5%)

42 (42.4%)

 

GVHD prevention

  

0.886

 CsA + MTX or CsA + MTX + MMF

42 (42.4%)

43 (43.4%)

 

 CsA + MTX + MMF + ATG

57 (57.6%)

56 (56.6%)

 

Grade of aGVHD

  

0.771

 Grade 2

36 (36.4%)

37 (37.4%)

 

 Grade 3

41 (41.4%)

44 (44.4%)

 

 Grade 4

22 (22.2%)

18 (18.2%)

 

No. of aGVHD involved organs

  

0.589

 1

25 (25.3%)

29 (29.3%)

 

 2

46 (46.5%)

48 (48.5%)

 

 3

28 (28.3%)

22 (22.2%)

 

aGVHD involved organs

  

0.860

 Skin

73 (73.7%)

63 (63.6%)

 

 Liver

43 (43.4%)

46 (46.5%)

 

 Upper GI

9 (9.1%)

10 (10.1%)

 

 Lower GI

79 (79.8%)

77 (77.8%)

 

Onset of aGVHD median days (range)

30 (14–132)

28 (16–124)

0.736

  1. GVHD graft-versus-host disease, SR steroid-resistant, MSCs mesenchymal stromal cells, AML acute myeloid leukemia, ALL acute lymphocyte leukemia, CR complete response, PR partial response, NR no response, HLA human leukocyte antigen, Bu busulfan, TBI total body irradiation, PBSC peripheral blood stem cells, BM bone marrow, CsA cyclosporine, MTX methotrexate, MMF mycophenolate mofetil, ATG antithymocyte globulin, GI gastrointestinal
  2. *Others included myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), multiple myeloma (MM), non-hodgkin lymphoma (NHL) and other acute leukemia