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Table 1 Baseline Characteristics of Patients

From: Decitabine in combination with fludarabine and cyclophosphamide as a lymphodepletion regimen followed by CD19/CD22 bispecific targeted CAR T-cell therapy significantly improves survival in relapsed/refractory B-ALL patients

Baseline characteristics of patients

Characteristic

DAC group (14)

Control group (12)

P value

Gender

 Male

10 (71.4%)

5 (41.7%)

0.233

 Female

4 (28.6%)

7 (58.3%)

Age, median

26.5 (8–52)

31 (16–74)

0.226

Ph + ALL, n (%)

2 (14.3%)

5 (41.7%)

0.190

Ph-like ALL, n (%)

3 (21.4%)

2 (16.7%)

1.000

White blood cell ≥ 50 × 10^9/L, n (%)

6 (42.9%)

2 (16.7%)

0.216

Extramedullary leukemia, n (%)

2 (14.3%)

0 (0%)

0.483

Monosomal karyotype, n (%)

0 (0%)

1 (8.3%)

0.462

Complex karyotype, n (%)

2 (14.3%)

2 (16.7%)

1.000

KMT2A rearranged, n (%)

1 (7.1%)

0 (0%)

1.000

TP53 mutation or deletion, n (%)

2 (14.3%)

0 (0%)

0.483

T315I mutation, n (%)

1 (7.1%)

2 (16.7%)

0.580

Poor-risk cytogenetics, n (%)

8 (57.1%)

8 (66.7%)

0.701

Prior cycles of therapy, median (range)

4 (2–16)

6.5 (1–20)

0.251

  < 5 cycles of therapy, n (%)

9 (64.3%)

4 (33.3%)

0.235

  ≥ 5 and < 10 lines of therapy, n (%)

2 (14.3%)

5 (41.7%)

  ≥ 10 cycles of therapy, n (%)

3 (21.4%)

3 (25%)

Primary refractory to chemotherapy, n (%)

2 (14.3%)

3 (25%)

0.635

Numbers of relapses, median (range)

1 (0–2)

1 (0–2)

0.685

Relapse after previous HSCT, n (%)

 Yes

6 (42.9%)

0 (0%)

0.017

 No

8 (57.1%)

12 (100%)

Blasts in BM before lymphodepletion treatment, median (range)

35.75 (5–82)

43.75 (6–85.5)

0.487

LDH, pre-lymphodepletion, median (range)

173.8 (106.5–644)

168.7 (83.6–722.2)

0.956

Ferritin, pre-lymphodepletion, median (range)

774.945 (234.06–2718.84)

1614.66 (411.63–2663.69)

0.140

CRP, pre-lymphodepletion, median (range)

5.115 (0.28–15.36)

1.195 (0.12–15.36)

0.170

ECOG, pre-lymphodepletion, median (range)

2 (1–3)

2 (1–3)

0.609

CAR T-cell dose, 10^7/kg, median (range)

1 (0.5–2)

1 (0.5–2.5)

0.950

Source of CAR T-cells, n (%)

 Autologous

10 (71.4%)

12 (100%)

0.100

 Donor-derived allogenic

4 (28.6%)

0 (0%)

Transduction rate (%), median

31.435 (13.02–64.35)

44.685 (6.07–63.92)

0.643