Table 2.

Nonhematologic and hematologic toxicities of clofarabine followed by cyclophosphamide

Toxicity	Dose level 1	Dose level 0
No. patients	6	12
Clofarabine-related fever	2	4
Tumor lysis syndrome	3; 1 grade 3	4; all grade ≤ 2
Cytokine release/ARDS	1 grade 3	1 grade 5
Renal failure	0	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	2
Meningitis, S epidermis		1
Ischemic colitis	1 grade 5	0
Fungal pneumonia	4	3; 1 grade 5
Death, no. patients (%)	2 (33)	2 (17)
Prolonged marrow aplasia	1	0
Fungal pneumonia	0	1
Multiorgan failure	1 with ischemic colitis	1

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).