Table 3.

Toxicity of LMB-2/fludarabine and cyclophosphamide in patients with ATL

Toxicity in >1 patientFludarabine and cyclophosphamide dose levels (mg/m2; all grade 3–5 toxicity)Fludarabine and cyclophosphamide dose levels (mg/m2)
All grades20 + 20025 + 25030 + 30020 + 20025 + 25030 + 300
Patients treatedn = 3n = 12n = 2n = 3n = 12n = 2
Neutropenia2 (67%)10 (83%)2 (100%)Neutropenia1 (33%)9 (75%)2 (100%)
Nausea/vomiting/anorexia2 (67%)10 (83%)2 (100%)Leukopenia/lymphopenia1 (33%)9 (75%)2 (100%)
Fever/chills1 (33%)10 (83%)1 (50%)Anemia0 (0%)8 (67%)0 (0%)
Leukopenia/lymphopenia1 (33%)9 (75%)2 (100%)Transaminases1 (33%)4 (33%)0 (0%)
Transaminases3 (100%)8 (67%)1 (50%)Thrombocytopenia0 (0%)5 (42%)1 (50%)
Hypotension/tachycardia1 (33%)8 (67%)2 (100%)Fever/chills0 (0%)3 (25%)1 (50%)
Thrombocytopenia1 (33%)8 (67%)2 (100%)Pneumonitis0 (0%)3 (25%)0 (0%)
Anemia0 (0%)9 (75%)1 (50%)Low CD4 count1 (33%)1 (8%)1 (50%)
Myalgia/headache2 (67%)7 (58%)2 (100%)Hypotension/tachycardia0 (0%)2 (17%)0 (0%)
Hypoalbuminemia2 (67%)6 (50%)1 (50%)Rectal hemorrhage0 (0%)1 (8%)0 (0%)
Hematuria1 (33%)5 (42%)1 (50%)Bilirubin0 (0%)1 (8%)0 (0%)
Proteinuria0 (0%)7 (58%)0 (0%)Dysuria0 (0%)1 (8%)0 (0%)
Fatigue/dizziness1 (33%)4 (33%)2 (100%)Bladder infection0 (0%)1 (8%)0 (0%)
Edema0 (0%)6 (50%)0 (0%)Hypoxia0 (0%)1 (8%)0 (0%)
Abdominal pain0 (0%)5 (42%)0 (0%)Proteinuria0 (0%)1 (8%)0 (0%)
Diarrhea1 (33%)3 (25%)0 (0%)Sepsis0 (0%)1 (8%)a0 (0%)
CPK0 (0%)4 (33%)0 (0%)
Mucositis0 (0%)3 (25%)1 (50%)
Hypomagnesemia0 (0%)3 (25%)0 (0%)
Bilirubin1 (33%)2 (17%)0 (0%)
Alkaline phosphatase/GGT0 (0%)3 (25%)0 (0%)
Pneumonitis0 (0%)3 (25%)0 (0%)
Low CD4 count1 (33%)1 (8%)1 (50%)
Lipase0 (0%)3 (25%)0 (0%)
Bladder infection0 (0%)2 (17%)0 (0%)
Dyspnea0 (0%)2 (17%)0 (0%)
Prothrombin time1 (33%)1 (8%)0 (0%)
Pruritus1 (33%)0 (0%)1 (50%)
  • aGrade 5 event.