Table 1.

Characteristics of patients with R/R B-ALL with CNSL at baseline (N = 48)

CharacteristicValue
Median age (range), y 31 (6-68) 
Age group, y  
 <40 32 (66.7) 
 ≥40 16 (33.3) 
Sex  
 Male 30 (62.5) 
 Female 18 (37.5) 
Disease status  
 BM + CNS 36 (75.0) 
 Isolated CNS 12 (25.0) 
Other EMDs*  
 Yes 9 (18.8) 
 No 39 (81.2) 
Poor-risk cytogenetics  
 Ph+ 20 (41.7) 
  T315I mutation 3 (6.3) 
  FLT3/ITD mutation 1 (2.1) 
  IKZF1 mutation 3 (6.3) 
  Ph-like§ǁ 3 (9.1) 
TP53 aberrationǁ 2 (6.1) 
MLL rearrangementǁ 4 (12.2) 
 Complex karyotype 2 (4.2) 
BM blasts before infusion, %  
 <5 22 (45.8) 
 ≥5 26 (54.2) 
CNS status before infusion  
 1 3 (6.3) 
 2 15 (31.2) 
 3 30 (62.5) 
Median prior treatment lines (range), n 4 (3-16) 
No. of relapses  
 1 25 (52.1) 
 2 13 (27.1) 
 ≥3 6 (12.5) 
 Primary refractory 4 (8.3)* 
Prior allo-HSCT  
 Yes 10 (20.8) 
 No 38 (79.2) 
Prior cranial irradiation  
 Yes 5 (10.4) 
 No 43 (89.6) 
CNS-directed bridging treatment  
 Yes 27 (56.3) 
 No 21 (43.7) 
Costimulator  
 4-1BB 32 (66.7) 
 CD28 5 (10.4) 
 CD28 + 4-1BB 11 (22.9) 
Infused cells  
 Isolated CD19 37 (77.1) 
 Combined CD19 + CD22 11 (22.9) 
Average dose, ×106/kg  
 <3 26 (54.2) 
 3-5 13 (27.0) 
 >5 9 (18.8) 
CharacteristicValue
Median age (range), y 31 (6-68) 
Age group, y  
 <40 32 (66.7) 
 ≥40 16 (33.3) 
Sex  
 Male 30 (62.5) 
 Female 18 (37.5) 
Disease status  
 BM + CNS 36 (75.0) 
 Isolated CNS 12 (25.0) 
Other EMDs*  
 Yes 9 (18.8) 
 No 39 (81.2) 
Poor-risk cytogenetics  
 Ph+ 20 (41.7) 
  T315I mutation 3 (6.3) 
  FLT3/ITD mutation 1 (2.1) 
  IKZF1 mutation 3 (6.3) 
  Ph-like§ǁ 3 (9.1) 
TP53 aberrationǁ 2 (6.1) 
MLL rearrangementǁ 4 (12.2) 
 Complex karyotype 2 (4.2) 
BM blasts before infusion, %  
 <5 22 (45.8) 
 ≥5 26 (54.2) 
CNS status before infusion  
 1 3 (6.3) 
 2 15 (31.2) 
 3 30 (62.5) 
Median prior treatment lines (range), n 4 (3-16) 
No. of relapses  
 1 25 (52.1) 
 2 13 (27.1) 
 ≥3 6 (12.5) 
 Primary refractory 4 (8.3)* 
Prior allo-HSCT  
 Yes 10 (20.8) 
 No 38 (79.2) 
Prior cranial irradiation  
 Yes 5 (10.4) 
 No 43 (89.6) 
CNS-directed bridging treatment  
 Yes 27 (56.3) 
 No 21 (43.7) 
Costimulator  
 4-1BB 32 (66.7) 
 CD28 5 (10.4) 
 CD28 + 4-1BB 11 (22.9) 
Infused cells  
 Isolated CD19 37 (77.1) 
 Combined CD19 + CD22 11 (22.9) 
Average dose, ×106/kg  
 <3 26 (54.2) 
 3-5 13 (27.0) 
 >5 9 (18.8) 

Data are presented as n (%) unless otherwise specified.

*

Extramedullary diseases other than CNS involvement.

From cytogenetic analysis performed at any time after diagnosis; some patients had >1 abnormality identified. All patients were screened for cytogenetic abnormalities using karyotyping, and 33 patients underwent next-generation sequencing covering gene fusions and pathogenic mutations recommended by National Comprehensive Cancer Network guidelines.

Screening assessment in 48 patients.

§

Including 3 Ph patients with EBF1-PDGFRB+ fusion (n = 2) and JAK2/PAX5 rearrangement (n = 1).

ǁ

Screening assessment in 33 patients.

Patients experiencing less than CR after initial induction therapy.

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