Table 2

Nonhematologic and hematologic toxicities of clofarabine followed by cyclophosphamide

ToxicityDose level 1Dose level 0
No. patients 12 
Clofarabine-related fever 
Tumor lysis syndrome 3; 1 grade 3 4; all grade ≤ 2 
Cytokine release/ARDS 1 grade 3 1 grade 5 
Renal failure 3; 2 grade 4 
Hepatic dysfunction 4; all grade 3 2; 1 grade 3 
Multiorgan dysfunction 1 grade 5 2; 1 grade 5 
Marrow aplasia longer than 42 d 4*; 1 grade 5 3 
Documented infections 8 events/5 patients 7 events/6 patients 
    Bacteremia, Gram positive 2; 1 grade 5 
    Meningitis, S epidermis  
    Ischemic colitis 1 grade 5 
    Fungal pneumonia 3; 1 grade 5 
Death, no. patients (%) 2 (33) 2 (17) 
    Prolonged marrow aplasia 
    Fungal pneumonia 
    Multiorgan failure 1 with ischemic colitis 
ToxicityDose level 1Dose level 0
No. patients 12 
Clofarabine-related fever 
Tumor lysis syndrome 3; 1 grade 3 4; all grade ≤ 2 
Cytokine release/ARDS 1 grade 3 1 grade 5 
Renal failure 3; 2 grade 4 
Hepatic dysfunction 4; all grade 3 2; 1 grade 3 
Multiorgan dysfunction 1 grade 5 2; 1 grade 5 
Marrow aplasia longer than 42 d 4*; 1 grade 5 3 
Documented infections 8 events/5 patients 7 events/6 patients 
    Bacteremia, Gram positive 2; 1 grade 5 
    Meningitis, S epidermis  
    Ischemic colitis 1 grade 5 
    Fungal pneumonia 3; 1 grade 5 
Death, no. patients (%) 2 (33) 2 (17) 
    Prolonged marrow aplasia 
    Fungal pneumonia 
    Multiorgan failure 1 with ischemic colitis 

Data are numbers of patients unless otherwise indicated.

*

One patient with MDS/AML recovered with leukemia day 75.

Two patients recovered with leukemia (days 55, 58).

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