Table 2.

Univariable and multivariable analyses of outcomes of interest based on patient characteristics in responding patients

CIRCumulative incidence of composite end point (relapse or loss of BCA)OS in responding patients
CharacteristicUnivariableMultivariableUnivariableMultivariableUnivariableMultivariable
HR95% CIPHR95% CIPHR95% CIPHR95% CIPHR95% CIPHR95% CIP
 Sex   .13      .40      .10   .69 
  Female Ref      Ref      Ref   Ref   
  Male 0.64 0.36-1.13     0.81 0.50-1.31     0.51 0.23-1.13  0.83 0.35-2.01  
 N of prior lines of therapy 1.09 0.92-1.28 .33    1.04 0.90-1.19 .63    1.16 0.93-1.45 .20    
 Time from diagnosis to infusion, mo 0.99 0.99-1.00 .20    1.00 0.99-1.00 .22    0.99 0.98-1.00 .31    
 Age at diagnosis, y   .005   .075   .052   .21   .011  0.14-0.80 .010 
  <1 or >10 Ref   Ref   Ref   Ref   Ref   Ref   
  1-10 0.43 0.24-0.78  0.55 0.29-1.06  0.62 0.39-1.00  0.72 0.43-1.21  0.34 0.14-0.80  0.34   
 Preinfusion disease burden   .006   .001   .014   .005   .013 Ref 1.20-7.00 .013 
  None or low Ref   Ref   Ref   Ref   Ref   2.90   
  High 2.26 1.25-4.10  2.66 1.45-4.87  1.82 1.13-2.95  2.02 1.24-3.29  2.88 1.19-6.96     
 Initial cytogenetic risk   .43      .54      .41    
  Favorable Ref      Ref      Ref      
  Intermediate 1.87 0.68-5.15     1.27 0.58-2.80     2.67 0.56-12.7     
  Unfavorable 1.68 0.62-4.53     1.51 0.71-3.24     1.96 0.42-9.11     
 Prior HCT   .92      .64      .88    
  No Ref      Ref      Ref      
  Yes 0.93 0.23-3.85     0.77 0.24-2.44     0.86 0.12-6.37     
 Prior CD19-directed therapy   .43      .82      .98    
  No Ref      Ref      Ref      
  Yes 1.32 0.67-2.61     1.07 0.60-1.90     1.01 0.38-2.71     
 Prior relapse   .062   .14   .55      .19    
  ≥1 Ref   Ref   Ref      Ref      
  Refractory 0.42 0.15-1.17  0.49 0.18-1.38  1.22 0.64-2.33     0.42 0.10-1.80     
 CNS or EM disease   .17      .93      .68    
  No Ref      Ref      Ref      
  Yes 1.50 0.84-2.68     1.02 0.64-1.64     0.84 0.37-1.90     
 Race   .98      .71      .73    
  Black/Hispanic Ref      Ref      Ref      
  Other 1.14 0.34-3.89     0.63 0.19-2.07     1.20 0.26-5.44     
  White 1.02 0.55-1.88           0.75 0.33-1.73     
 Cumulative fludarabine AUC, mg × h/L   .029   .005   .025   .010   .056   .14 
  ≥13.8 Ref   Ref   Ref   Ref   Ref   Ref   
  <13.8 1.95 1.08-3.52  2.45 1.34-4.48  1.77 1.09-2.88  1.96 1.19-3.23  2.25 1.00-5.06  1.97 0.80-4.85  
CIRCumulative incidence of composite end point (relapse or loss of BCA)OS in responding patients
CharacteristicUnivariableMultivariableUnivariableMultivariableUnivariableMultivariable
HR95% CIPHR95% CIPHR95% CIPHR95% CIPHR95% CIPHR95% CIP
 Sex   .13      .40      .10   .69 
  Female Ref      Ref      Ref   Ref   
  Male 0.64 0.36-1.13     0.81 0.50-1.31     0.51 0.23-1.13  0.83 0.35-2.01  
 N of prior lines of therapy 1.09 0.92-1.28 .33    1.04 0.90-1.19 .63    1.16 0.93-1.45 .20    
 Time from diagnosis to infusion, mo 0.99 0.99-1.00 .20    1.00 0.99-1.00 .22    0.99 0.98-1.00 .31    
 Age at diagnosis, y   .005   .075   .052   .21   .011  0.14-0.80 .010 
  <1 or >10 Ref   Ref   Ref   Ref   Ref   Ref   
  1-10 0.43 0.24-0.78  0.55 0.29-1.06  0.62 0.39-1.00  0.72 0.43-1.21  0.34 0.14-0.80  0.34   
 Preinfusion disease burden   .006   .001   .014   .005   .013 Ref 1.20-7.00 .013 
  None or low Ref   Ref   Ref   Ref   Ref   2.90   
  High 2.26 1.25-4.10  2.66 1.45-4.87  1.82 1.13-2.95  2.02 1.24-3.29  2.88 1.19-6.96     
 Initial cytogenetic risk   .43      .54      .41    
  Favorable Ref      Ref      Ref      
  Intermediate 1.87 0.68-5.15     1.27 0.58-2.80     2.67 0.56-12.7     
  Unfavorable 1.68 0.62-4.53     1.51 0.71-3.24     1.96 0.42-9.11     
 Prior HCT   .92      .64      .88    
  No Ref      Ref      Ref      
  Yes 0.93 0.23-3.85     0.77 0.24-2.44     0.86 0.12-6.37     
 Prior CD19-directed therapy   .43      .82      .98    
  No Ref      Ref      Ref      
  Yes 1.32 0.67-2.61     1.07 0.60-1.90     1.01 0.38-2.71     
 Prior relapse   .062   .14   .55      .19    
  ≥1 Ref   Ref   Ref      Ref      
  Refractory 0.42 0.15-1.17  0.49 0.18-1.38  1.22 0.64-2.33     0.42 0.10-1.80     
 CNS or EM disease   .17      .93      .68    
  No Ref      Ref      Ref      
  Yes 1.50 0.84-2.68     1.02 0.64-1.64     0.84 0.37-1.90     
 Race   .98      .71      .73    
  Black/Hispanic Ref      Ref      Ref      
  Other 1.14 0.34-3.89     0.63 0.19-2.07     1.20 0.26-5.44     
  White 1.02 0.55-1.88           0.75 0.33-1.73     
 Cumulative fludarabine AUC, mg × h/L   .029   .005   .025   .010   .056   .14 
  ≥13.8 Ref   Ref   Ref   Ref   Ref   Ref   
  <13.8 1.95 1.08-3.52  2.45 1.34-4.48  1.77 1.09-2.88  1.96 1.19-3.23  2.25 1.00-5.06  1.97 0.80-4.85  

Bold font indicates significance.

CNS, central nervous system; HCT, hematopoetic cell transplantation; Ref, reference.

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