Table 1 Characteristics of the patients.

From: Myeloablative conditioning with thiotepa-busulfan-fludarabine does not improve the outcome of patients transplanted with active leukemia: final results of the GITMO prospective trial GANDALF-01

 

All patients enrolled (n = 101)

Transplanted patients (n = 87)

Relapsed patients (n = 40)

Refractory patients (n = 47)

Non transplanted patients (n = 14)

Age (years), median (range)

54 (19–69)

52 (19–69)

46 (19–67)

54 (23–69)

62.5 (20–68)

Sex

  Female

45 (44.6)

40 (46)

20 (50)

20 (42.6)

5 (35.7)

  Male

56 (55.4)

47 (54)

20 (50)

27 (57.4)

9 (64.3)

Previous auto HSCT

9 (8.9)

8 (9.2)

5 (12.5)

3 (6.4)

1 (7.1)

Diagnosis

  Acute myeloid leukemia

93 (92.1)

82 (94.0)

36 (90.0)

46 (97.9)

11 (78.6)

   de novo

79 (84.9)

69 (84.1)

34 (94.4)

35 (76.1)

10 (90.9)

   Secondary

13 (14.0)

12 (14.6)

2 (5.6)

10 (21.7)

1 (9.1)

   Therapy-related

1 (1.1)

1 (1.2)

0

1 (2.2)

0

  Acute Lymphoblastic Leukemia

8 (7.9)

5 (5.7)

4 (10.0)

1 (2.1)

3 (21.4)

   de novo

7 (87.5)

4 (80.0)

3 (75)

1 (100)

3 (100)

   Secondary

1 (12.5)

1 (20.0)

1 (25)

0

0 (0)

   B-lineage

7 (87.5)

4 (80.0)

3 (75)

1 (100)

3 (100)

   T- lineage

1 (12.5)

1 (20.0)

1 (25)

0

0 (0)

   Ph pos

2 (25.0)

1 (20.0)

1 (50)

0

1 (33.3)

Cytogenetics

  Low riska

3 (3)

3 (3.4)

2 (5)

1 (2.1)

0

  Intermediate riska

49 (48.5)

43 (49.4)

23 (57.5)

20 (42.6)

6 (42.9)

  High riska

36 (35.6)

29 (33.3)

10 (25)

19 (40.4)

7 (50)

  Unknown

13 (12.9)

12 (13.8)

5 (12.5)

7 (14.9)

1 (7.1)

Molecular biology

  BCR-ABL mutated

2/96 (2.1)

1/82 (1.2)

1/37 (2.6)

0/44

1/14 (7.1)

  AF4-MLL mutated

1/6 (16.7)

0/3

0/2

0/1

1/3 (33.3)

  AML1 ETO mutated

2/91 (2.2)

2/80 (2.5)

1/36 (2.8)

1/44 (2.3)

0/11

  FLT3-ITD mutated

21/91 (23.1)

19/80 (23.8)

12/36 (33.3)

7/44 (15.9)

2/11 (18.2)

  CEBPA mutated

1/90 (1.1)

1/79 (1.3)

1/36 (2.8)

0/43

0/11

  NPM1 mutated

24/90 (26.7)

21/79 (26.6)

15/36 (41.7)

6/43 (14)

3/11 (27.3)

  MLL-PTD mutated

1/90 (1.1)

1/79 (1.3)

1/36 (2.8)

0/43

0/11

Sorror score

  0

39 (38.6)

33 (37.9)

13 (32.5)

20 (42.6)

6 (42.9)

  1

43 (42.6)

39 (44.8)

19 (47.5)

20 (42.6)

4 (28.6)

  2

11 (10.9)

10 (11.5)

5 (12.5)

5 (10.6)

1 (7.1)

  3

7 (6.9)

5 (5.7)

3 (7.5)

2 (4.3)

2 (14.3)

  >3

1 (1.0)

0 (0)

0 (0)

0 (0)

1 (7.1)

Blasts PB % at enrollement

30 (0–100)

28.5 (0–100)

40 (0–95)

21 (0–100)

70 (4–100)

Platelets ×109/L at enrollement

34 (3–471)

36 (3–471)

35 (3–327)

43 (6–471)

22 (10–165)

Ferritin ng/mL at enrollement

1757 (25–7745)

1740 (122–6853)

1836 (122–6853)

1700 (460–5565)

1914 (25–7745)

Albumin, g/L at enrollement

42 (12–63)

42 (12–63)

43 (12–60.2)

41 (27–63)

40 (30–44.5)

Donor typeb

  URD

48 (55.2)

48 (55.2)

25 (62.5)

23 (48.9)

   10/10 matched

26 (54.2)

26 (54.2)

11 (44.0)

15 (65.2)

   mis-matched

17 (35.4)

17 (35.4)

12 (48.0)

5 (21.7)

  CB

6 (6.9)

6 (6.9)

11 (27.5)

2 (4.3)

  Haploidentical

33 (37.9)

33 (37.9)

4 (10.0)

22 (46.8)

Female donor for male recipientb

18 (20.7)

18 (20.7)

6 (15.0)

12 (25.5)

HSC sourceb

  PBSC

44 (50.6)

44 (50.6)

25 (62.5)

19 (40.4)

  BM

37 (42.5)

37 (42.5)

11 (27.5)

26 (55.3)

  CB

6 (6.9)

6 (6.9)

4 (10.0)

2 (4.3)

CMV serostatusb

  R CMV+/D CMV+

42 (51.2)

42 (51.2)

19 (48.7)

23 (53.5)

  R CMV+/D CMV−

30 (36.6)

30 (36.6)

15 (38.5)

15 (34.9)

  R CMV-/D CMV+

6 (7.3)

6 (7.3)

3 (7.7)

3 (7)

  R CMV−/D CMV−

4 (4.9)

4 (4.9)

2 (5.1)

2 (4.7)

Conditioning regimenb

  TBF-full

82 (94.3)

82 (94.3)

37 (92.5)

45 (95.7)

  TBF- reduced intensity

4 (4.6)

4 (4.6)

2 (5.0)

2 (4.3)

  Other

1 (1.1)

1 (1.1)

1 (2.5)

0

  1. HSCT hematopoietic stem cell transplantation, URD unrelated donor, CB cord blood, HSC hematopoietic stem cell source, PBSC peripheral blood stem cells, BM bone marrow, CMV cytomegalovirus, R recipient, D donor, TBF thiotepa, busulfan, fludarabine.
  2. aAML patients with t(inv16), t(8:21) were cytogenetically considered as low-risk patients; those with normal karyotype, trisomy of chromosome (chr) 8, trisomy of chr 21, del 12(p13), additional chr 16 and 1 as intermediate and, finally, those showing complex karyotype, monosomy or other abnormalities of chr. 5 and 7, 17p-, as high risk; ALL patients with t(9:22), t(4;11) and abnormalities of 11 were considered high-risk cytogenetics.
  3. bOnly patients transplanted.