Table 1.

Baseline demographics and disease characteristics (full analysis set)

CharacteristicPatients (N = 116)
Sex, n (%)  
 Male 68 (59) 
 Female 48 (41) 
Median (range) age, years 45.0 (18-76) 
Age group, years, n (%)  
 18 to <35 36 (31) 
 35 to <55 41 (35) 
 55 to <65 24 (21) 
 ≥65 15 (13) 
Cytogenetics/molecular genetics, n (%)  
 t(9;22)/BCR-ABL+ 5 (4) 
 t(4;11)/MLL-AF4+ 5 (4) 
Relapse history, n (%)*  
 Patients in first CR 75 (65) 
 Patients in second CR 39 (34) 
 Patients in third CR 2 (2) 
Median (range) time from last prior treatment, months 2.0 (0-55) 
Baseline MRD levels, n (%)  
 ≥10−1 to <1 (≥10% to <1) 9 (8) 
 ≥10−2 to <10−1 (≥1% to <10%) 45 (39) 
 ≥10−3 to <10−2 (≥0.1% to <1%) 52 (45) 
 <10−3 (<0.1%) 3 (3) 
 Below LLOQ 5 (4) 
 Unknown 2 (2) 
CharacteristicPatients (N = 116)
Sex, n (%)  
 Male 68 (59) 
 Female 48 (41) 
Median (range) age, years 45.0 (18-76) 
Age group, years, n (%)  
 18 to <35 36 (31) 
 35 to <55 41 (35) 
 55 to <65 24 (21) 
 ≥65 15 (13) 
Cytogenetics/molecular genetics, n (%)  
 t(9;22)/BCR-ABL+ 5 (4) 
 t(4;11)/MLL-AF4+ 5 (4) 
Relapse history, n (%)*  
 Patients in first CR 75 (65) 
 Patients in second CR 39 (34) 
 Patients in third CR 2 (2) 
Median (range) time from last prior treatment, months 2.0 (0-55) 
Baseline MRD levels, n (%)  
 ≥10−1 to <1 (≥10% to <1) 9 (8) 
 ≥10−2 to <10−1 (≥1% to <10%) 45 (39) 
 ≥10−3 to <10−2 (≥0.1% to <1%) 52 (45) 
 <10−3 (<0.1%) 3 (3) 
 Below LLOQ 5 (4) 
 Unknown 2 (2) 

LLOQ, lower limit of quantification.

*

One patient was ineligible (hematologic relapse).

Nine patients had MRD levels ≥10−1 with bone marrow cytology in central reference laboratory showing <5% blasts.

Missing MRD assay results in central reference laboratory (n = 1); MRD quantification at baseline but with subsequent assessments (n = 1).

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